Heartfelt Device for Heart Failure
(HEARTFELT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new remote monitoring device, the Heartfelt device, to help manage heart failure. The goal is to determine if the device can safely reduce hospital visits by alerting healthcare providers when patients show signs of worsening. Participants will either receive regular care or use the device to compare effectiveness. Those who have had heart failure for at least two months, have recently been hospitalized or had emergency visits for heart failure, and currently take daily diuretics (medication to reduce fluid retention) might find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart failure management strategies.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking diltiazem or verapamil regularly.
What prior data suggests that the Heartfelt device is safe for monitoring heart failure?
Research has shown that the Heartfelt device is generally safe for patients. In a recent study, only 1.8% of 20,000 users experienced negative side effects, indicating that very few people had issues.
Another study with 26 patients reported some heart failure events, but these were not directly caused by the device.
Overall, the Heartfelt device is well-tolerated, with few safety concerns reported.12345Why are researchers excited about this trial?
The Heartfelt Device is unique because it provides continuous monitoring and transmits real-time volume measurements and health alerts to healthcare providers. Unlike traditional treatments for heart failure that may rely on periodic check-ups and patient-reported symptoms, this device allows for proactive management and timely interventions based on up-to-date data. Researchers are excited about its potential to improve patient outcomes by enabling more personalized and responsive care, potentially reducing hospital visits and enhancing quality of life for patients with heart failure.
What evidence suggests that the Heartfelt device is effective for heart failure?
Research has shown that the Heartfelt device effectively detects swelling in the legs and feet, a potential sign of worsening heart failure. This device provides more reliable and quicker information than current tools. In this trial, participants in the "Standard Care + Heartfelt" arm will have the device installed, capturing and transmitting data for review. This may lead to earlier detection of heart failure issues. Studies indicate that the device can increase the number of days with accurate monitoring, aiding in the earlier identification of heart failure problems. This could result in fewer hospital visits for heart failure patients, offering better care and reducing emergencies for those using the device.13567
Who Is on the Research Team?
WH Wilson Tang, MD
Principal Investigator
Cleveland Clinic, USA
Are You a Good Fit for This Trial?
The HEARTFELT Study is for adults with chronic heart failure who've been hospitalized for it in the past year, often miss collecting their health data, and have had peripheral edema. They must be on daily diuretics, agree to install a monitoring device at home, and follow remote care plans. Women of childbearing age should use effective contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Washout Period 1
Initial washout period to prevent carryover between study arms
Standard Care (Control)
Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP
Washout Period 2
Second washout period to prevent carryover between study arms
Standard Care + Heartfelt (Intervention)
Device captures data and transmits volume measurements and health alerts to the RPMP for review
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension (Optional)
Participants may opt into continuation of treatment long-term with randomized 100-day periods in 'Standard care' mode
What Are the Treatments Tested in This Trial?
Interventions
- Heartfelt Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Heartfelt Technologies
Lead Sponsor