Digital Monitoring for Heart Failure

(ADHERE-HF Trial)

Enrolling by invitation at 1 trial location

Overseen By Nicholas Hendren, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Substance abuse, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a digital monitoring system can improve heart care for patients with systolic heart failure, a condition where the heart doesn't pump effectively. Participants will either continue their usual care or add a digital solution from the American Heart Association, which includes a wearable device and a care plan. The researchers aim to determine if this digital approach helps more people follow heart health guidelines. The trial seeks adults diagnosed with heart failure who have an ejection fraction of 40% or less. Participants must also have access to a smartphone and the internet. As an unphased trial, this study offers a unique opportunity to contribute to innovative heart care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual care, but it's best to confirm with the study team.

What prior data suggests that this device is safe for heart failure patients?

Research has shown that the Biofourmis Digital Platform is safe and easy for heart failure patients to use. In one study, patients found the platform comfortable and encountered no major problems. Another study used the platform with a small group of heart failure patients to adjust and improve their treatment plans. No significant reports of negative effects have emerged from using the platform, suggesting it is generally safe for managing heart conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Biofourmis Digital Platform for heart failure because it offers a new way to manage the condition using digital technology. Unlike traditional treatments that rely heavily on medications and regular in-person doctor visits, this platform uses a digital solution combining the American Heart Association's CarePlans and education content. It integrates with the Biofourmis Platform to provide continuous monitoring and personalized care remotely. This approach could lead to more timely interventions and better disease management, potentially reducing hospitalizations and improving quality of life for patients with heart failure.

What evidence suggests that this digital solution is effective for heart failure?

Research shows that digital tools like the Biofourmis Digital Platform can help manage heart failure more effectively. In this trial, participants will receive either routine care or routine care plus the American Heart Association's Digital Solution, which includes the Biofourmis platform. An initial study found that patients with heart failure had better results when using the Biofourmis platform. This tool adjusts medications based on real-time information, helping people follow the best treatment plan. The American Heart Association has combined this platform with specific care plans to enhance its effectiveness. Overall, early findings suggest that this digital solution could improve heart failure management. ^{1 2 3 4 6}

Who Is on the Research Team?

Nicholas Hendren, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

Adults over 18 with heart failure and a left ventricular ejection fraction of 40% or less. They must have had an echocardiogram or cardiac MRI within the last year to confirm their condition.

Inclusion Criteria

I am over 18 with heart failure and my heart's pumping ability is reduced.

Exclusion Criteria

Survival anticipated <6 months

I have severe kidney disease or am on dialysis.

Unable or unwilling to consent or use study related materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive usual care or usual care plus the AHA Digital Solution for heart failure management

12 weeks

Multiple visits (phone, Mychart, clinic visit)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biofourmis Digital Platform

Trial Overview The trial is testing the Biofourmis Digital Platform, which includes a wearable device and care plan package. It's designed to see if it can improve adherence to heart failure treatment guidelines compared to usual care alone.

How Is the Trial Designed?

Group I: Device Experimental Treatment 1 Intervention

Participants will receive usual care or usual care plus the American Heart Association's Digital Solution in patients with HFrEF. The Solution is a combination of the AHA/CHTI HF CarePlans and Education Content, delivered through and combined with the Biofourmis Platform.

Group II: Routine Care Active Control 1 Intervention

Routine care for heart failure management

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

The study involved 38 older adults with heart failure, comparing a sensor-controlled digital game (SCDG) intervention to a sensors-only approach over 12 weeks, showing that the SCDG was feasible and well-accepted for encouraging daily weight monitoring and physical activity.

Participants using the SCDG demonstrated a strong correlation between app engagement and adherence to weight monitoring and physical activity, suggesting that gamification can effectively motivate health behaviors in older adults with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Sensor-Controlled Digital Game for Heart Failure Self-management: Randomized Controlled Trial. Radhakrishnan, K., Julien, C., Baranowski, T., et al.[2022]

The Biomon-HF project developed and tested innovative sensors for monitoring vital signs during sleep in 115 heart failure patients, showing promise for personalized telemonitoring and therapy management.

These sensors can help detect heart failure exacerbations and related health issues early, potentially reducing complications and healthcare costs while improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized biomonitoring in heart failure--Biomon-HF "Keep an eye on heart failure--especially at night". Vollmer, T., Schauerte, P., Zink, M., et al.[2015]

Patient-reported outcomes (PROs) are essential for capturing the real-life impact of heart failure on patients, including their symptoms and quality of life, but are not routinely included in clinical trials.

To improve the relevance of PROs in heart failure research and patient care, there is a need for standardized measures and methods for data collection and analysis, as well as further research to establish clinically important thresholds for these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives. Zannad, F., Alikhaani, J., Alikhaani, S., et al.[2023]

The study involved 92 participants with chronic heart failure, who were randomly assigned to either a mobile health intervention group using the iCardia4HF app and connected devices or a control group with only the devices, to assess the feasibility and preliminary efficacy of the intervention.

The main focus was on improving adherence to heart failure self-care practices, such as medication and weight monitoring, with follow-up assessments at 30 days and 12 weeks, while also tracking hospitalizations and emergency visits for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-centered mobile health technology intervention to improve self-care in patients with chronic heart failure: Protocol for a feasibility randomized controlled trial. Kitsiou, S., Gerber, BS., Kansal, MM., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1071916425001435

A Digital Platform to Optimize Guideline-Directed Heart ... Outcomes for patients living with heart failure remain suboptimal, in part due to underuse of available heart failure pharmacological therapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10580132/

Feasibility and Acceptability of a Combined Digital Platform ... Digital platforms designed for remote monitoring of HF can improve clinical outcomes, but their effectiveness has been limited by patient barriers such as lack ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.030952

Challenge of Optimizing Medical Therapy in Heart Failure Wong and colleagues successfully applied this approach in a pilot study of 20 patients with HFrEF using the Biofourmis platform that adjusted ...

4. biofourmis.com biofourmis.com/news-insights/fdas-first-ever-device-designation-for-heart-failure-digital-medicine

Biofourmis Earns FDA's First-Ever Breakthrough Device ... BiovitalsHF is a software medical application that augments guideline-directed use of heart failure medications to manage patients in combination with ...

5. biofourmis.com biofourmis.com/news-insights/biofourmis-selected-by-american-college-of-cardiology-as-exclusive-virtual-care-platform-for-cardiovascular-study

Biofourmis Selected by American College of Cardiology as ... Access to care and improved care management can change those outcomes. For example, in the U.S., heart failure affects an estimated 6 ...

6. tctmd.com tctmd.com/news/aim-power-remote-app-based-intervention-boosts-gdmt-use-hfref

Remote, App-Based Intervention Boosts GDMT Use in HFrEF A digital intervention helps physicians make personalized treatment recommendations for patients with heart failure with reduced ejection fraction (HFrEF)