Background Patients with heart failure (HF) with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) have a high comorbidity burden, which may require management with numerous medications. Patients and clinicians may be hesitant about initiating another medication, especially among individuals with polypharmacy. Objective This study sought to examine the efficacy and safety of adding finerenone based on the number of concomitant medications in patients with HFmrEF/HFpEF. Methods In this post hoc analysis of the FINEARTS-HF trial, baseline medication use was collected in all 6,001 participants with HFmrEF/HFpEF who were randomized to finerenone or placebo. Clinical outcomes were assessed by medication use categories (“non-polypharmacy”: <5 medications; “polypharmacy”: 5 to 9 medications; and “hyper-polypharmacy”: ≥10 medications) and continuously, adjusted for covariates including age. The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events. Results Overall (age: 72±10 years; 46% women), the total number of medications at baseline ranged from 0 to 29 and the mean number of medications was 8.4±3.6, with 3,588 (60%) patients met polypharmacy and 1,878 (31%) met hyper-polypharmacy. Patients with higher medication use were older and had a greater burden of comorbidities. Incidence rates for the primary outcome increased across medication categories: non-polypharmacy (10.2 per 100py), polypharmacy (12.3 per 100py), and hyper-polypharmacy (26.1 per 100py) (Figure A). The treatment benefits of finerenone in reducing risks of cardiovascular death and total HF events were consistent across the spectrum of total medication use (P for interaction = 0.94; Figure B). Although adverse events leading to study drug discontinuation increased with the higher number of medications, they were not more frequent with finerenone vs. placebo, regardless of polypharmacy categories. Conclusions In the FINEARTS-HF trial, >90% of patients with HFmrEF/HFpEF met the criteria for polypharmacy and these patients faced excess risks of cardiovascular events. Finerenone safely reduced cardiovascular death and total HF events across a broad range of baseline medication use, including among individuals with polypharmacy.
To integrate clinical and preclinical evidence on insulin-like growth factor-binding protein-7 (IGFBP7) in heart failure (HF) and identify key priorities for advancing IGFBP7-targeted therapies toward human translation. Circulating IGFBP7 is strongly associated with HF development, diastolic dysfunction, and disease progression across HF phenotypes. Preclinical studies show that genetic or pharmacologic inhibition of IGFBP7 attenuates cardiac remodelling, reduces cardiomyocyte senescence, and ameliorates cardiac dysfunction in murine HF models. Apparent mechanistic discrepancies between studies likely reflect cell-specific actions: cardiomyocyte-derived IGFBP7 activates IGF-1 receptor signalling, promoting cardiomyocyte hypertrophy and senescence, whereas endothelial-derived IGFBP7 inhibits cardiomyocyte insulin receptor signalling, impairing metabolic homeostasis. IGFBP7 is a senescence-associated biomarker linked to HF development, diastolic dysfunction, and HF progression. Preclinical studies converge on the conclusion that IGFBP7 inhibition attenuates cardiac remodelling and ameliorates cardiac dysfunction in experimental HF, positioning IGFBP7 as a promising therapeutic target. Ongoing research into IGFBP7-targeted strategies may expand HF treatment beyond conventional hemodynamic and neurohormonal interventions by directly addressing the biology of cardiovascular ageing and senescence-driven myocardial dysfunction.
Social determinants of health (SDoH) are increasingly recognized as key drivers of clinical outcomes, yet they remain underutilized in predictive models for patients with heart failure (HF). 1 While clinical tools exist to estimate the risk of in-hospital mortality, few integrate social risk factors alongside biomedical variables. 2 In this study, we assessed the added value of incorporating adverse SDoH into machine learning-based survival models for predicting in-hospital mortality or hospice discharge in hospitalized HF patients.
AIMS:Clinicians may be less inclined to consider new therapies in patients with long-standing heart failure (HF) due in part to clinical inertia. Whether the treatment effects of the non-steroidal mineralocorticoid receptor antagonist finerenone vary according to HF duration remains uncertain. METHODS:In this prespecified analysis of the FINEARTS-HF trial, HF duration (defined as the time from diagnosis) was categorized into four groups: <3 months, ≥3 months to 2 years, ≥2 to 5 years, or ≥5 years. The primary outcome was a composite of cardiovascular death and total HF events. The efficacy and safety of finerenone were analyzed across the duration of HF. RESULTS:Among 5,977 participants with available data (age: 72±10 years; 46% female), those with longer duration HF were older and had a higher comorbidity burden, while most patients, irrespective of HF duration, had NYHA class II functional status. Compared with HF duration <3 months, longer HF duration experienced a significantly higher adjusted risk of the primary outcome. The benefit of finerenone was consistent across HF duration categories: the rate ratio (95%CI) for the primary outcome in the <3-month group was 0.84 (0.61-1.16); ≥3 months to 2 years, 0.95 (0.74-1.23); ≥2 to 5 years, 0.77 (0.61-0.98); and ≥5 years, 0.81 (0.64-1.02) (Pinteraction=0.46). Drug discontinuation due to serious adverse events was similar between finerenone and placebo, regardless of HF duration. CONCLUSIONS:These findings suggest that even patients with long-standing HF with only mild functional status limitation may still benefit from further therapeutic optimization with therapies such as finerenone.
Background Noninvasive remote patient monitoring (RPM) captures and transmits physiological (eg, weight) and symptom data to the patient’s care team for monitoring outside of the clinic, creating opportunities for early intervention (eg, medical therapy optimization) to avoid decompensation events. Mixed results in studies of noninvasive RPM may stem from the complex design of heart failure programs. In current RPM study reports, many workflow components including data review and clinical responses are reported ambiguously or not at all. Opaque workflows prevent robust evaluation, replication in other studies, and community implementation of heart failure RPM programs. Objectives The purpose of this study was to create a set of recommendations and a template for reporting workflow design in the publication of noninvasive RPM studies. Methods The Heart Failure Collaboratory, Canadian Heart Failure Society, and members of the European Society of Cardiology formed a multidisciplinary working group. Through an extensive consensus-building process, the authors reviewed existing workflows and data reporting practices and developed “the 6 Rs” of RPM Reporting. Results The authors created a set of recommendations and a template for reporting workflows that is organized around 6 Rs: patient Representativeness, ambulatory data Recording, data Relay to clinicians, clinician data Review, Response, and Recommendations from patients and providers. Conclusions Systematic use of the 6 Rs of RPM Reporting template will improve the completeness and transparency of workflow reporting of RPM studies. The authors encourage investigators to use this framework and accompanying template during noninvasive RPM trial planning and include completed templates in study publications or as supplemental materials.
AIMS:Heart failure (HF) disproportionately affects older patients, yet evidence guiding management in the oldest and frailest patients remains limited. We evaluated the influence of age and frailty on mortality and use of guideline-directed medical therapy (GDMT). METHODS AND RESULTS:Using nationwide Danish registry data, we identified all patients with new-onset HF (2013-2022), stratified by age (<65, 65-79, ≥80 years) and frailty status according to the Hospital Frailty Risk Score (low, intermediate, high). We assessed all-cause and cardiovascular mortality two years after HF diagnosis and evaluated GDMT use across age and frailty groups using logistic regression. Among 79,193 patients with HF, 24% were aged <65 years, 41% 65-79, and 35% ≥80. Frailty significantly modified the association between age and mortality (interaction p<0.001). Patients with high frailty reached comparable two-year mortality risks at younger ages than patients with lower frailty. The following had similar two-year mortality: low-frailty patients aged 80 years (22.1%, 95% CI, 21.4-22.8), intermediate-frailty patients aged 70 years (22.8%, 21.9-23.8), and high-frailty patients aged 47 (22.8%, 18.0-28.4). Similar results were seen for cardiovascular mortality. GDMT use was lower in high frailty than low frailty patients across all age groups. Moreover, within each frailty group, patients aged ≥80 years had lower odds of receiving GDMT compared to those aged <65 (reference). CONCLUSION:Frailty alters mortality risk in HF beyond chronological age, resulting in prognostic heterogeneity regardless of age. Our findings support the need for both frailty-informed and age-based management strategies in HF across all ages.
BACKGROUND AND AIMS:The frequency and prognostic significance of abnormalities in serum magnesium concentrations have not been described in a contemporary heart failure (HF) population. The authors evaluated the prognostic significance of magnesium concentrations in patients with HF with reduced ejection fraction (HFrEF) enrolled in GALACTIC-HF trial. METHODS:GALACTIC-HF was a randomized, double-blind, multicentre, event-driven trial that investigated the efficacy and safety of omecamtiv mecarbil compared with placebo in HF patients with left ventricular ejection fraction ≤ 35%. The primary outcome was the composite of a first worsening HF event or cardiovascular death. RESULTS:A total of 6147 outpatients had baseline serum magnesium data. Of these, 1082 (17.6%) had magnesium concentrations below .75 mmol/L, 4410 (71.7%) had concentrations within the normal range, and 655 (10.7%) had concentrations above .95 mmol/L. The incidence rate (per 100 person-years) for the primary composite outcome was highest in patients with hypermagnesaemia (34.9, 95% confidence interval 31.2-39.0), while rates were similar between those with hypomagnesaemia (21.5, 19.4-23.8), and normal magnesium (20.9, 19.9-22.0). Similar trends were observed for the components of the primary outcome and all-cause death. The incidence rate of sudden death and ventricular tachyarrhythmia did not differ among the three magnesium groups, but the risk of death from worsening HF was highest in patients with hypermagnesaemia. CONCLUSIONS:In GALACTIC-HF, 10.7% of outpatients with HFrEF had hypermagnesaemia, which was associated with a higher risk of the primary outcome compared with normal magnesium concentrations. Abnormal magnesium levels were not associated with a higher risk of sudden death or ventricular tachyarrhythmias. These findings do not support routine correction of hypomagnesaemia.
Heart failure (HF) remains a major cause of morbidity, mortality and costs for the healthcare systems worldwide, despite advances in diagnostic and therapeutic strategies. The enhancement of preventive measures is now a priority, but effective prevention requires a multidisciplinary strategy addressing a broad spectrum of comorbidities and risk factors. It must also consider the changes in the prevailing phenotype of the patients with HF with a lower impact of coronary artery disease and the increasing role of renal and metabolic conditions leading mostly to HF with preserved ejection fraction. Prevention of HF must take into consideration arterial hypertension, chronic kidney disease, diabetes mellitus, sedentary lifestyle, obesity, dyslipidemia, female-specific risk factors, as well as adverse effects of chemotherapy and radiotherapy. Other key factors include infections and the protective role of vaccination, and environmental and socio-economic determinants of health. In 2022, a position paper of the Heart Failure Association and the European Association of Preventive Cardiology of the ESC was published as a complete overview on this topic and as a compendium to the 2021 ESC Guidelines on HF. However, since then, significant evidence has emerged regarding the potential to prevent HF, particularly in the context of metabolic disorders, diabetes and kidney diseases. This scientific statement aims to provide an updated perspective, highlighting the importance of a holistic and tailored approach to managing the multifaceted contributors to this syndrome.
Background: Global clinical trials collect extensive unstructured medical records that richly describe participants’ clinical presentation, but their narrative format precludes quantitative analysis. Converting these records into structured data could reveal new insights into events like heart failure hospitalization (HFH) but is prohibitively labor intensive. Varied documentation styles, translated text, and scanned or handwritten documents challenge data extraction in clinical trials. Research Question: Can a carefully prompted large language model (LLM) accurately extract structured data on the clinical presentation of HFHs from unstructured adjudication dossiers in a global trial? Methods: We extracted structured data for 51 variables—symptoms, signs, laboratory values, imaging findings, and treatments—from unstructured medical record dossiers in the DELIVER trial utilizing a prompting workflow for the OpenAI o1-mini LLM. We validated LLM-extracted data with physician chart review in a random sample of 125 dossiers and calculated the accuracy, positive predictive value (PPV), and negative predictive value (NPV). A second physician reviewed 25 dossiers to assess inter-reviewer reproducibility. The validated model was applied to extract presenting features in all 1,111 HFHs in the trial. Results: LLM-extracted data achieved high overall accuracy of 0.96 (95% CI: 0.96–0.97), PPV of 0.94 (95% CI: 0.93–0.95), and NPV of 0.97 (95% CI: 0.97–0.98) on physician validation. Accuracy exceeded 0.90 for all variables except numeric BNP and Troponin I, where errors mainly reflected confusion between biomarker subtypes (BNP vs NT-proBNP or troponin I vs T). The reproducibility of human review was 98%. In the full trial, dyspnea (92%), peripheral edema (68%), pulmonary crackles (51%), congestion on chest imaging (59%) and natriuretic peptide elevation (65%) were reported frequently. Mean peri-admission ejection fraction was 46% ± 12% (n=481 with available data), vs a baseline mean of 53% ± 9%. Intravenous diuretics were used in 85% of hospitalizations, and oral diuretic doses were increased in 45%. Conclusion: A prompt-engineered LLM accurately extracted structured data, including signs and symptoms, laboratory and imaging data from adjudication dossiers at scale in a global clinical trial to generate a structured useable database. LLM-based data extraction could be extended to unlock quantitative insights from a wide range of narrative trial records.
AIMS:The association between heart rate (HR) and clinical outcomes is well understood in patients with heart failure with reduced ejection fraction (HFrEF) but less clear in those with HFmrEF/HFpEF, especially among individuals with atrial fibrillation (AF). In a prespecified analysis of the FINEARTS-HF trial, we examined the association between baseline HR and clinical outcomes by heart rhythm and evaluated finerenone's effect across the spectrum of HR. METHODS:The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events. Heart rhythm (sinus rhythm or AF) was determined from the baseline ECG. Patients with pacemaker rhythm or missing HR/rhythm data were excluded. RESULTS:Among patients with sinus rhythm (SR n = 3497; 62%), higher baseline HR was associated with a higher incidence rate for the primary outcome. In patients with AF (n = 2190; 38%), no association between HR and outcomes was observed. The effect of finerenone on the primary outcome was consistent across the HR spectrum, regardless of rhythm (P for interaction = 0.96 in SR; 0.49 in AF). In patients with SR, there was no significant HR change with finerenone versus placebo. In AF patients, finerenone led to a small but statistically significant HR reduction: a placebo-corrected decrease of 1.35 bpm (95% CI: 0.41-2.29) from baseline to 12 months. CONCLUSIONS:Among patients with HFpEF/HFmrEF in FINEARTS-HF, higher baseline HR was associated with a higher risk of the primary outcome in patients with SR but not in those with AF. Finerenone's effect on the primary outcome was consistent across the HR spectrum, irrespective of rhythm. TRIAL REGISTRATION:ClinicalTrials.gov NCT04435626.
BACKGROUND AND AIMS:The initiation of heart failure (HF) therapies at the time of detection of an elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in community-based patients with suspected HF may reduce the risk of early adverse outcomes. The aim of this analysis was to estimate the potential benefit of the early initiation of a sodium-glucose cotransporter 2 inhibitor (SGLT2i) and/or mineralocorticoid receptor antagonist (MRA) in patients with suspected HF and a pre-existing non-HF-related indication for treatment. METHODS:A cohort study was performed from 1 January 2015 to 31 March 2023 using linked primary and secondary care data from the Clinical Practice Research Datalink (CPRD). Patients without a history of HF and who were not prescribed an SGLT2i or MRA were followed up for 12 months following a community-measured NT-proBNP ≥ 400 pg/mL. The primary outcome was a composite of a HF hospitalization as the first recorded HF diagnostic event or death from any cause in patients without a documented HF diagnosis during follow-up and who did not undergo echocardiography. The effect of the initiation of treatment with an SGLT2i, MRA, or both (effective treatments for HF regardless of ejection fraction) was modelled at the time of NT-proBNP measurement in patients with a pre-existing non-HF-related indication for these drugs (Type 2 diabetes, chronic kidney disease, or resistant hypertension) using treatment effect estimates from meta-analyses of randomized placebo-controlled trials in patients with established HF. RESULTS:An NT-proBNP ≥ 400 pg/mL was recorded in 74 945, 24 082 (32%) of whom had a HF diagnosis recorded within 12 months, 15 398 (64%) as an outpatient and 8684 (36%) during a HF hospitalization. If both an SGLT2i and MRA were commenced at the measurement of an elevated NT-proBNP in those with a pre-existing non-HF-related indication, we estimated that for every 1000 patients treated, 84 would avoid either a HF hospitalization or death at 12 months, equating to a number needed to treat of 12 (95% confidence interval 11-14). CONCLUSIONS:In community-based patients with suspected HF and elevated NT-proBNP, the early initiation of an SGLT2i and an MRA in patients with a pre-existing non-HF-related indication for treatment may reduce the risk of early adverse outcomes whilst awaiting diagnostic echocardiography. These findings suggest a simple clinical strategy with potentially large public health benefits.
BACKGROUND Noninvasive remote patient monitoring (RPM) captures and transmits physiological (eg, weight) and symptom data to the patient's care team for monitoring outside of the clinic, creating opportunities for early intervention (eg, medical therapy optimization) to avoid decompensation events. Mixed results in studies of noninvasive RPM may stem from the complex design of heart failure programs. In current RPM study reports, many workflow components including data review and clinical responses are reported ambiguously or not at all. Opaque workflows prevent robust evaluation, replication in other studies, and community implementation of heart failure RPM programs. OBJECTIVES The purpose of this study was to create a set of recommendations and a template for reporting workflow design in the publication of noninvasive RPM studies. METHODS The Heart Failure Collaboratory, Canadian Heart Failure Society, and members of the European Society of Cardiology formed a multidisciplinary working group. Through an extensive consensus-building process, the authors reviewed existing workflows and data reporting practices and developed "the 6 Rs" of RPM Reporting. RESULTS The authors created a set of recommendations and a template for reporting workflows that is organized around 6 Rs: patient Representativeness, ambulatory data Recording, data Relay to clinicians, clinician data Review, Response, and Recommendations from patients and providers. CONCLUSIONS Systematic use of the 6 Rs of RPM Reporting template will improve the completeness and transparency of workflow reporting of RPM studies. The authors encourage investigators to use this framework and accompanying template during noninvasive RPM trial planning and include completed templates in study publications or as supplemental materials. (JACC Heart Fail. 2026;14:102849) (c) 2026 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
ABSTRACT Background Increased public access to data from disparate sources provides opportunities to study and validate predictive and subphenotype models in heterogeneous disease conditions using aggregated individual patient data. Robust, explicit, and transparent harmonization of data elements is critical to ensure interpretability, reproducibility, and generalizability of secondary and retrospective analyses. Methods & Results We designed and implemented ADAPT (Aggregating Data to Accelerate Personalized Therapy), a scalable framework using multiple software packages (R, SQL, BigQuery) that enables rapid, explicit harmonization of structured data elements from randomized trials and observational studies using a standard spreadsheet interface. User-specified criteria are applied to primary study data to produce harmonized longitudinal datasets comprised of demographics, medical history, quantitative observations, repeated measures, and clinical outcomes. We demonstrate this functionality using 26 clinical studies found in the National Heart, Lung, and Blood Institute’s BioLINCC resource. We illustrate the scalability of ADAPT to the order of billions of datapoints using administrative clinical data in a cloud-computing platform. We also present examples of collaborators using ADAPT for independent harmonization tasks for secondary analyses and democratization of publicly available data. Conclusion ADAPT is a disease-agnostic, extensible, and scalable platform to support robust, transparent harmonization of structured research data using interfaces accessible to a variety of researchers regardless of programming ability. It extends FAIR principles beyond research data to also represent harmonization analyses by improving F indability of harmonization decisions, A ccessibility of methods to other stakeholders, I nteroperability with independent analyses and datasets, and R eusability through efficient implementation in a variety of analysis environments.
Heart failure with reduced ejection fraction (HFrEF) imposes a significant clinical burden on patients and a major economic burden on healthcare systems. In HFrEF, mineralocorticoid receptor antagonists (MRAs) constitute a cornerstone of guideline-directed medical therapy (GDMT) reducing both mortality and hospitalisation. Their use in practice remains suboptimal, largely because of physicians' concerns about adverse events, particularly hyperkalaemia, which may deprive eligible patients of benefit. Only the steroidal MRAs spironolactone and eplerenone are approved for HFrEF, and this consensus document is restricted to these agents. We summarise contemporary evidence across multiple domains related to MRA therapy in HFrEF, including pharmacoepidemiology, the role of biomarkers in predicting outcomes and response to MRA, the pathological role of aldosterone and the pharmacology and clinical efficacy of steroidal MRAs. Practical, evidence-based guidance is provided on the prevention and management of hyperkalaemia, the timing of MRA initiation, and strategies to overcome barriers to MRA use. The positioning of MRAs in current guidelines is outlined to reinforce their central role in HFrEF. The process of consensus finding was started in April 2025 with a core group by online conference. We searched PubMed with the terms "MRA, eplerenone and heart failure with reduced ejection fraction". Articles published in English with no date restriction were considered. The final manuscript passed two rounds of final approval by all authors. As a result, this consensus statement advocates proactive, evidence-based approaches to optimise MRA use to improve outcomes. These recommendations aim to mitigate the persistent underuse of MRAs in clinical practice.
Introduction and Objective: Hypokalemia is associated with adverse cardiovascular outcomes in heart failure (HF) and may impair insulin release and action. However, whether hypokalemia promotes incident diabetes in HF is uncertain. Methods: In this FINEARTS-HF analysis, we evaluated the association between time-updated serum potassium levels and new-onset diabetes, defined as ≥2 HbA1c measurements ≥6.5% or initiation of a non-SGLT2i glucose-lowering medication. We also examined whether time-updated potassium accounted for the benefit of finerenone on new-onset diabetes. Results: Among 6,001 participants, 3,224 (54%) did not have diabetes at baseline and were included (mean age 72 ± 10; 47% female; mean HbA1c, 5.7% ± 0.4%). Over a median follow-up of 2.7 years, lower time-updated serum potassium levels were significantly associated with new-onset diabetes after multivariable adjustment (hazard ratio [HR] per 0.5 mmol/L decrease, 1.19; 95% CI, 1.04-1.36; P=0.012) (Figure 1A). Treatment effects of finerenone on new-onset diabetes (HR, 0.76; 95% CI, 0.59-0.97) were partially attenuated after accounting for time-updated serum potassium levels (HR, 0.80; 95% CI, 0.62-1.03; 19.3% mediated) (Figure 1B). Conclusion: These findings extend understanding of the adverse health effects of hypokalemia in HF and suggest hypokalemia avoidance may have favorable metabolic effects. Benefits of finerenone on new-onset diabetes appear to be primarily mediated through potassium-independent pathways. Disclosure J. Ostrominski: Advisory Panel; Current; Corcept Therapeutics. H. Lu: Advisory Panel; Current; Boehringer Ingelheim International GmbH. Other - Travel expenses; Current; Bayer AG. Advisory Panel; Current; AstraZeneca. Other - Travel expenses; Ended; Cytokinetics Inc., Abbott. P. Jhund: Research Support; Ended; AstraZeneca. Speaker's Bureau; Current; AstraZeneca. Advisory Panel; Current; Novo Nordisk. Consultant; Current; Bayer AG. Research Support; Current; Analog Devices, Roche Diagnostics. A. Voors: Consultant; Current; Anacardio, AstraZeneca, Bayer AG. Research Support; Current; Bayer AG. Consultant; Ended; Boehringer Ingelheim International GmbH. Consultant; Current; Cardurion, Corteria, Eli Lilly and Company. Consultant; Ended; Merck & Co., Inc., Novartis AG. Consultant; Current; Novo Nordisk. Research Support; Current; Novo Nordisk. Consultant; Current; QYSense, Ryarna, Salubris. M. Brinker: Employee; Current; Bayer AG. Other - pending patent for finerenone for treatment of patients with CKD and T1D; Current; Bayer AG. Stock/Shareholder; Current; Bayer AG. Y. De Sanctis: Employee; Current; Bayer AG. S.D. Solomon: Research Support; Current; Alexion, Alnylam, Applied Therapeutics, AstraZeneca, Bellerophon, Bayer, BMS, Boston Scientific, Cardior, Cytokinetics, Edgewise, BridgeBio, Gossamer, GSK, Ionis, Lilly, NIH/NHLBI, Novartis, NovoNordis. Consultant; Current; Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, Askbio, AstraZeneca, Bayer, BMS, Bridgebio, Cardior, Cardurion, Corvia, Cytokinetics, GSK, Intellia, Lilly, Novartis, Roche, Theracos, Quantu. M. Vaduganathan: Other - research grant support, served on advisory boards, or had speaker engagements; Current; Alnylam Pharmaceuticals, American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, BMS, Boehringer Ingelheim, Chiesi, Cytokinetics, Esperion, Fresenius Medical Care, Idorsia Pharmaceuticals, L, Novartis, Novo Nordisk, Pharmacosmos, Recordati, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health. Research Support; Current; Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim, Galmed, Impulse Dynamics, Novartis, Occlutech, and Pharmacosmos. A. Scalise: None. L. Hofmeister: Employee; Current; Bayer AG.
Background The importance of nutritional status is underappreciated in patients with heart failure (HF). This study aimed to describe the range of the prognostic nutrition index (PNI), and the clinical characteristics and outcomes according to PNI, in patients with HF with preserved ejection fraction (HFpEF) and reduced ejection fraction (HFrEF). The primary outcome was the composite of HF hospitalization or cardiovascular death.Methods and Results Individual patient data from the PARAGON-HF (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] with ARB [Angiotensin Receptor Blocker] Global Outcomes in HFpEF) and PARADIGM-HF (Prospective Comparison of ARNI With ACEI [Angiotensin-Converting Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in HF) trials were used to examine patient characteristics and outcomes according to quartiles of PNI. Cox regression was used to analyze clinical outcomes, and multivariable fractional polynomial interaction analysis to examine the effects of sacubitril-valsartan, according to PNI. Patients with lower PNI (poorer nutrition) were older, frailer, and had more comorbidities and worse HF status, with greater congestion. Patients with lower PNI had biomarker abnormalities indicating inflammation, bone marrow suppression, and increased collagen turnover, among other physiologic perturbations. Lower PNI was associated with worse outcomes; that is, the rate of the primary end point among patients in the first quartile was 11.31 (10.20-12.54) compared with 7.09 (6.17-8.14) per 100 person-years in the fourth quartile. These associations persisted after adjustment for other prognostic variables. PNI did not modify the effects of sacubitril-valsartan in HFrEF although sacubitril/valsartan seemed to have a greater benefit in patients with HFpEF with a higher PNI.Conclusions Nutritional status, assessed using PNI, is an independent predictor of poor outcomes in HF. Evaluation of nutritional status in clinical practice, the causes of undernutrition, and whether undernutrition should be a therapeutic target, are all worthy of further investigation in HF.
Background An initial decline in estimated glomerular filtration rate (eGFR) often leads to reluctance to continue life-saving therapies in patients with heart failure (HF). Objectives The goal of this study was to describe the association between initial decline in eGFR and subsequent clinical outcomes in patients randomized to placebo or finerenone. Methods In this prespecified analysis of FINEARTS-HF (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure), we examined the association between initial decline in eGFR (≥15%) from randomization to 1 month and subsequent outcomes in patients assigned to finerenone or placebo. The primary outcome was the composite of total HF events and cardiovascular death. Results Among 5,587 patients with an eGFR measurement at both baseline and 1 month, 1,018 (18.2%) experienced a ≥15% decline in eGFR. The proportion of patients experiencing a ≥15% decline in eGFR was 23.0% with finerenone and 13.4% with placebo (OR: 1.95; 95% CI: 1.69-2.24; P < 0.001). After adjustment, an eGFR decline was associated with a higher risk of the primary outcome in patients assigned to placebo (adjusted rate ratio: 1.50; 95% CI: 1.20-1.89) but not in those assigned to finerenone (adjusted rate ratio: 1.07; 95% CI: 0.84-1.35; Pinteraction = 0.04). By contrast, the efficacy of finerenone was consistent across the range of change in eGFR from baseline to 1 month (Pinteraction = 0.50 for percent change in eGFR), and safety, including hyperkalemia, was similar regardless of an early eGFR decline. Conclusions Although an initial decline in eGFR was associated with worse outcomes in patients assigned to placebo, this relationship was not as strong in those treated with finerenone. An early decline in eGFR can be anticipated with finerenone and should not automatically lead to the discontinuation of this disease-modifying therapy (FINEARTS-HF Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure [NCT04435626]; A Multicenter, Randomized, Double-Bline, Parallel-Group, Placebo-Controlled Study to Evaluate the efficacy and safety of finerenone on morbidity and mortality in participants With Heart Failure [NYHA II-IV] and left ventricular ejection fraction ≥40% [EudraCT 2020-000306-29]).
It is well established that video monitoring is effective in promoting self-care among patients with heart failure during the intervention period. However, its long-term impact on sustaining self-care behaviors after discontinuation remains unclear. This article describes a randomized clinical trial protocol designed to assess the effectiveness of a video monitoring strategy in maintaining self-care behaviors in patients with heart failure with reduced ejection fraction (HFrEF). This is a randomized, parallel trial with blinded outcome assessment. During hospitalization, eligible patients will be invited to participate. Data collection will include sociodemographic and clinical variables, laboratory test results, current medications, and cardiovascular physical examination. Validated instruments will measure clinical congestion, self-care (European HF Self-Care), HF knowledge, treatment adherence, quality of life, and cardiorespiratory fitness. The control group (CG) will receive standard care after discharge. In the intervention group (IG), the discharge summary will be shared with primary healthcare providers (nurse and physician) to facilitate transitional care. IG participants will receive structured video monitoring sessions with specialized cardiovascular nursing support at 7, 30, 60, 180, and 365 days post-discharge, focusing on self-care reinforcement. The primary outcome is the self-care score at one year. Secondary outcomes include quality of life, HF knowledge, treatment adherence, cardiorespiratory fitness, mortality, and hospital readmissions. Unlike mobile-based or voice telemonitoring strategies, video monitoring fosters a stronger connection between patients and healthcare professionals, which may enhance self-care maintenance over time. This approach aligns with personalized nursing interventions, reinforcing education and behavioral changes beyond the intervention period. This study highlights the role of video monitoring in sustaining self-care practices in heart failure management. By strengthening the nurse-patient relationship and promoting long-term adherence, it has the potential to reduce readmissions and mortality rates. Video monitoring may enhance global nursing practices, improving outcomes and quality of life for heart failure patients.