Heartfelt Device for Heart Failure

(HEARTFELT Trial)

Recruiting at 2 trial locations

Overseen By Amparito Cunningham, MD. MPH.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Heartfelt Technologies

Must be taking: Diuretics

Must not be taking: Diltiazem, Verapamil

Disqualifiers: Amputation, Wheelchair, Bed-bound, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1500 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 3 5 6 7}

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

I was hospitalized for heart failure in the last year.

I have been diagnosed with chronic heart failure.

I take daily diuretic medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Washout Period 1

Initial washout period to prevent carryover between study arms

3 weeks

Standard Care (Control)

Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP

23 weeks

Washout Period 2

Second washout period to prevent carryover between study arms

3 weeks

Standard Care + Heartfelt (Intervention)

Device captures data and transmits volume measurements and health alerts to the RPMP for review

23 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension (Optional)

Participants may opt into continuation of treatment long-term with randomized 100-day periods in 'Standard care' mode

Up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Heartfelt Device

Trial Overview

This study tests if the Heartfelt Device can reduce hospital visits by better tracking swelling in patients' legs due to heart failure. It compares standard care with Heartfelt-guided care using questionnaires and remote patient monitoring calls over a period of up to five years.

How Is the Trial Designed?

Group I: Standard Care + Heartfelt (intervention) Experimental Treatment 4 Interventions

Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).

Group II: Standard Care (control) Active Control 3 Interventions

Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.

Who Is Running the Clinical Trial?

Heartfelt Technologies

Lead Sponsor

Trials

7

Recruited

2,000+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S0147956324001432

Assessing the Heartfelt Device's Predictive Value in Heart ...

The Heartfelt device demonstrates superior capability in detecting peripheral edema indicative of heart failure worsening, offering more reliable data ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06222099

Study Details | NCT06222099 | The HEARTFELT Study

Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. Secondary objectives: Establish the effect ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06334822

Study Details | NCT06334822 | Randomised Controlled ...

It is a 6 months crossover randomised controlled trial designed to evaluate the effectiveness of the Heartfelt device, a remote patient monitoring system, in ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1071916423005377

The Foot Study, Observational Retrospective Multi-center ...

The Heartfelt device can directly detect the increase in peripheral edema associated with heart failure decompensation and provides significantly more days with ...

5.

hftech.org

hftech.org/

Heartfelt Technologies

Heartfelt Technologies exists to help patients, their families, carers and doctors, to reduce hospital readmission rates from heart failure decompensation.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1071916423005377

The Foot Study, Observational Retrospective Multi-center ...

Of 26 patients with the Heartfelt device installed, there were 9 HF events recorded across 8 patients. These were 2 outpatient events, 6 hospitalizations, and 1 ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12568234/

Invasive and Non-Invasive Remote Patient Monitoring ...

Recent post-market surveillance data has further stressed the safety of the device, with a mean 1.8% adverse event rate (as of early 2021, historical n = 20,000) ...