Wearable Sensors to Monitor Physical Activity in Heart Failure Clinical Trials: State-of-the-Art Review

Background Estimation of the effect that a drug or other intervention has on patient symptoms and functions is crucial in heart failure trials. Traditional symptoms and functions clinical outcome assessments have important limitations. Actigraphy may help to overcome these limitations due to its objective nature and the potential for continuous recording of data. However, actigraphy is not currently accepted as clinically relevant by key stakeholders. Methods and Results In this This State-of-the-Art paper, the key aspects to consider when implementing actigraphy in heart failure trials are discussed. These include which actigraphy-derived measures should be considered, how to build endpoints with them, how to measure and analyze them, and how to handle the patient and site logistics of integrating devices into trials. A comprehensive recommendation based on the current evidence is provided. Conclusion Actigraphy is technically feasible in heart failure clinical trials, but successful implementation and use to demonstrate clinically important differences in physical functioning with drug or other interventions requires careful consideration of many design choices. Lay Summary People living with heart failure experience a high burden of symptoms and functional limitations but ways to measure and report this are currently limited. Actigraphy using wearable devices provides an opportunity to objectively measure continuous physical activity and changes over time, including in clinical trials of drug therapy. Despite the potential advantages, actigraphy to evaluate treatment benefits remains in its infancy. This State-of-the-Art paper provides comprehensive recommendations about how to successfully implement actigraphy in HF clinical trials, including the type of devices, the measurements to be taken, how to analyses these, and how best to describe the changes seen.