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Clinical Trial

The HEARTFELT Study

NCT: NCT06222099 · RECRUITING

NCT IDNCT06222099
StatusRECRUITING
Start Date2025-10-23
Completion2030-12-31

Brief Summary

This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives: 1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes. Participants will need to: * Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.

Frequently Asked Questions

What is The HEARTFELT Study?

The HEARTFELT Study is a clinical trial registered under NCT06222099. Current status: RECRUITING.

What is the status of NCT06222099?

The current status of NCT06222099 (The HEARTFELT Study) is: RECRUITING.

When did The HEARTFELT Study start?

The HEARTFELT Study started on 2025-10-23.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.