Intensive Blood Pressure Lowering Improves Left Ventricular Geometry in Older Hypertensive Patients: The STEP Trial

Background The effect of intensive systolic blood pressure (SBP) lowering on left ventricular (LV) geometry remains unclear. Methods Patients with hypertension aged 60–80 years without prior stroke were enrolled from 42 centers across China from January 2017. Eligible patients were randomly assigned to intensive (target: 110 to <130 mmHg) or standard (target: 130 to < 150 mmHg) SBP-lowering treatment. LV mass (LVM) was assessed by two-dimensional, M-mode, color flow Doppler echocardiography. LV hypertrophy (LVH) was diagnosed according to LVM index (LVMI) to height1.7 using sex-specific thresholds. Results Baseline demographic and LV parameters were comparable between the groups (n = 5709). During the median follow-up of 2.63 years, intensive treatment was associated with a lower risk of new LVH (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.69–1.00, P = 0.051) and greater regression of mean LVMI by 0.38 g/m1.7 per year (95% CI 0.05–0.71, P = 0.024). The rate of baseline LVH regression did not differ between the groups. Male patients achieved a significantly greater benefit from intensive treatment than female patients in terms of new LVH prevention and baseline LVH regression (both P for interaction <0.10). The favorable effect of intensive treatment on the cardiovascular outcome (HR 0.73, 95% CI 0.54–1.00) was slightly attenuated after adjusting for LVMI as a time-varying covariate (HR 0.75, 95% CI 0.55–1.03). Conclusions In older patients with hypertension, intensive SBP lowering offers additional cardiovascular benefits in terms of LV geometry. This favorable effect partially explains the reduction in cardiovascular events. Trial registration [Clinicaltrials.gov][1] (Identifier: [NCT03015311][2]) Condensed Abstract This is the first randomized controlled trial with a sufficient sample size to compare the effect of intensive systolic blood pressure (SBP) lowering (<130 mmHg) on echocardiographic left ventricular (LV) geometry with that of standard SBP lowering (< 150 mmHg) in older patients with hypertension. A lower risk of new LV hypertrophy development and greater regression of LV mass index were observed in patients with intensive treatment than in those with standard treatment. This favorable effect partially explains the reduction in cardiovascular events associated with intensive SBP lowering. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial [Clinicaltrials.gov][1] (Identifier: [NCT03015311][2]) ### Funding Statement This work was supported by CAMS Innovation Fund for Medical Sciences (CIFMS, 2021-I2M-1-007), National High Level Hospital Clinical Research Funding (2022-GSP-GG-5, 2022-GSP-PT-12, 2023-GSP-QN-2), National Natural Science Foundation of China (81825002, 82300504), Beijing Outstanding Young Scientist Program (BJJWZYJH01201910023029), Beijing Municipal Science & Technology Commission (Z191100006619106), and Key Project of Science and Technology Innovation Project of China Academy of Chinese Medical Sciences (CI2021A00920). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This trial was approved by the ethics committee of FuWai Hospital and all collaborating centers. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as [ClinicalTrials.gov][1]. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data that support the findings of this study are available from the corresponding author upon reasonable request. * IVSTd : interventricular septal end-diastolic thickness LVH : left ventricular hypertrophy LVIDd : left ventricular end-diastolic internal diameter LVMI : left ventricular mass index PWTd : posterior wall end-diastolic thickness RCT : randomized controlled trial RWT : relative wall thickness SBP : systolic blood pressure STEP : Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients Trial [1]: http://Clinicaltrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03015311&atom=%2Fmedrxiv%2Fearly%2F2024%2F04%2F01%2F2024.03.04.24303756.atom