BridgeMD
New treatment option for Heart Failure
Official title The HEARTFELT Study
ClinicalTrials.gov ID: NCT06222099
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Provision of signed and dated informed consent form (wet or digital signature)
- Male or female, aged 22 to [No maximum age]
- Diagnosed with Chronic Heart failure at least 2 months prior to randomization
- Documented history of peripheral edema (edema in feet and lower legs), defined as at least one clinical mention in the medical record indicative of...
- Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following: a.Hospitalization for...
See the full eligibility criteria
- Provision of signed and dated informed consent form (wet or digital signature)
- Male or female, aged 22 to [No maximum age]
- Diagnosed with Chronic Heart failure at least 2 months prior to randomization
- Documented history of peripheral edema (edema in feet and lower legs), defined as at least one clinical mention in the medical record indicative of oedema during prior clinical assessment.
- Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following: a.Hospitalization for heart failure occurring at least once in the past 6 months or at least...
- Patients who are treated with daily diuretics.
- Evidence of non-adherence defined by one or more of the following:
- Participants with ≥180 days of historical monitoring/device data available
- Failure to collect ≥50% of expected days of prescribed home physiological monitoring data (e.g. weight, blood pressure, or other clinician-recommended measurements), assessed over a continuous 180-day period; OR
- Discontinuation from a remote patient monitoring/home monitoring program due to non-adherence; OR
- Failure to adhere to a prescribed home-based therapy/monitoring intervention, supported by device usage data showing \<50% of expected days of use over a continuous 180-day period.
- Participants without ≥180 days of historical monitoring/device data available: Evidence of non-adherence may be demonstrated by low data capture over shorter windows, defined as any of the following :
- ≤2 days of monitoring data recorded for each of the most recent 4 consecutive weeks during which any remote monitoring device was continuously available in the patient's home; OR
- ≤3 days of monitoring data recorded in any consecutive 8 week period period during which any remote monitoring device was continuously available in the patient home; AND/OR
- by documented non-adherence in the medical record within the last 3 years:
- Historical documentation of persistent medication and/or dietary non-adherence, defined as either a clear statement of ongoing non-adherence or ≥2 documented instances of non-adherence concerns (including dosing and/or...
- Historical documentation on repeated clinical assessments indicating persistent difficulty adhering to recommended self-management activities (e.g. repeated failure to follow monitoring instructions, incomplete...
- For participants not previously enrolled in RPM or without sufficient historical monitoring data, non-adherence will be assessed prospectively using connected scales provided at study initiation. Objective adherence...
- Clinical teams/PIs discretion as patients being non-adherent.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the...
- Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare Part-B), OR written contract signed by the patient, or their provider or payor, stating that they will be liable for any...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Hackensack, New Jersey, United States
- Bala-Cynwyd, Pennsylvania, United States
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Hackensack, New Jersey, United States; Bala-Cynwyd, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.