Digital Platform Optimization for Heart Failure

(AIM-POWER Trial)

Recruiting at 18 trial locations

Overseen By Faisal Syed, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Biofourmis Inc.

Must be taking: GDMT for HFrEF

Disqualifiers: Dialysis, Heart transplant, Cirrhosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a digital platform called BiovitalsHF manages heart failure treatment. It specifically targets patients with heart failure and a reduced ability to pump blood (ejection fraction of 40% or less). The platform is compared to standard care to improve medication dosing and management. Suitable candidates for this trial have heart failure with reduced ejection fraction and are not currently receiving optimal treatment. As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance heart failure management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on optimizing heart failure treatment, so your current medications might be adjusted.

What prior data suggests that the BiovitalsHF platform is safe for heart failure patients?

Research has shown that the BiovitalsHF platform is generally safe to use. One study reported 21 negative effects in patients using the BiovitalsHF system, similar to the 18 negative effects in a group not using the system. This suggests that the platform does not significantly increase the risk of negative effects.

The platform aids in managing heart failure by using digital tools to monitor health and adjust medication. It collects health data and suggests medication changes based on this information. Overall, it appears to be a well-tolerated option for those managing heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BiovitalsHF platform because it offers a new way to manage heart failure treatment by using remote monitoring technology. Unlike traditional methods where patients need frequent in-person visits for medication adjustments, BiovitalsHF allows healthcare providers to monitor patients' conditions and adjust treatment from a distance. This approach could lead to more timely interventions and personalized care, potentially improving patient outcomes and quality of life. The platform streamlines the management of guideline-directed medical therapy (GDMT) and has the potential to make heart failure treatment more efficient and accessible.

What evidence suggests that the BiovitalsHF platform is effective for optimizing heart failure treatment?

Research has shown that the BiovitalsHF platform, which participants in this trial may receive, can help manage heart failure with reduced ejection fraction by using digital tools to improve medication use. Studies have found that this platform employs wearable devices and scales to collect data and suggest medication adjustments, ensuring patients receive the correct dosage at the right time. Although some early studies did not show a reduction in hospital visits for heart failure, they did identify improved methods for patient monitoring. The FDA has recognized the platform as a breakthrough device, highlighting its potential in managing heart failure. ^{1 3 6 7 8}

Who Is on the Research Team?

Akshay Desai, MD

Principal Investigator

Brigham and Womens Hospital

Adam Devore, MD

Principal Investigator

Duke Clinical Research Institute

Are You a Good Fit for This Trial?

This trial is for adults with heart failure where the heart's left ventricle doesn't pump well (ejection fraction ≤ 40%). They should be on less than the recommended dose of medications for heart failure, diagnosed over 3 months ago, and have a functional class II-III. Excluded are those with significant other diseases, poor kidney function, very low blood pressure, severe lung issues or liver cirrhosis, among others.

Inclusion Criteria

I have heart failure and am not on full doses of my heart failure medications.

I am taking less than the full dose of two heart failure medications.

I was diagnosed with heart failure with reduced ejection fraction over 3 months ago.

Exclusion Criteria

Subject determined likely to be non-compliant by physician/HCP

You currently have or are planning to have a left ventricular assist device.

My asthma is not well-managed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention arm are remotely monitored for 90 days using the BiovitalsHF platform to manage initiation and titration of GDMT

12 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BiovitalsHF

Trial Overview The study tests BiovitalsHF—a digital platform using wearable sensors to optimize medication doses for heart failure treatment according to guidelines. Participants will be randomly assigned to either use this AI-driven tool or continue their usual care without it in real-world settings.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Subjects randomized to the Intervention Arm will be remotely monitored for 90 days using the BiovitalsHF platform to manage initiation and titration of GDMT with and outside of normal or traditional clinical encounters.

Group II: Control Active Control 1 Intervention

Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.

Who Is Running the Clinical Trial?

Biofourmis Inc.

Lead Sponsor

Trials

5

Recruited

1,700+

Published Research Related to This Trial

The Heart Failure Collaboratory developed a streamlined case report form (CRF) for heart failure clinical trials, reducing the number of data items from 176 to 75 baseline items and 6 events, which aims to improve trial efficiency and reduce administrative burdens.

This new consensus CRF, created with input from various stakeholders including patients and the FDA, is designed to enhance data compatibility across trials, ultimately improving the integrity of evidence collected in heart failure device development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. Psotka, MA., Fiuzat, M., Carson, PE., et al.[2020]

A digital solution called SK-141 was found to be highly acceptable among heart failure patients, with an 80% retention rate over an 8-week study involving 20 participants, indicating strong patient engagement.

Clinical outcomes showed promising trends towards improvement, suggesting that remote monitoring and self-care support could enhance the quality of life for heart failure patients, warranting further research in a larger, controlled study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outpatient care for heart failure through digital innovation: a feasibility study. Arnar, DO., Oddsson, SJ., Gunnarsdottir, T., et al.[2022]

Sacubitril-valsartan has been shown to significantly reduce cardiovascular mortality and hospitalizations related to heart failure, highlighting its efficacy as a new treatment option.

Other emerging therapies like ivabradine and ferric carboxymaltose have also proven effective in reducing hospitalizations for heart failure, indicating a promising expansion of treatment options for managing chronic heart failure and acute decompensated heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving therapies for the management of chronic and acute decompensated heart failure. Cook, JC., Tran, RH., Patterson, JH., et al.[2021]

Heart failure (HF) is becoming increasingly prevalent, especially among older adults, and the current treatment methods are not effectively tailored to individual patient needs, highlighting the need for a new approach.

The proposed solution involves a predictive, preventive, and personalized medicine strategy using an AI-driven online application that empowers patients to manage their own care, potentially improving outcomes and reducing healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. Barrett, M., Boyne, J., Brandts, J., et al.[2020]

Recent advances in heart failure (HF) treatment include new medications and devices that have been integrated into clinical practice, aiming to improve patient outcomes and reduce hospitalizations.

The review identifies common issues in current HF clinical studies and emphasizes the need for further research to address existing gaps, ultimately striving for better management of HF and decreased morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reappraisal on pharmacological and mechanical treatments of heart failure. Liang, B., Zhao, YX., Zhang, XX., et al.[2020]

Citations

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

A Digital Platform to Optimize Guideline-Directed Heart ... Using wearable home-based monitors and digital scales, the BiovitalsHF platform assembled data regarding patients' status and formulated ...

2. onlinejcf.com onlinejcf.com/article/S1071-9164(25)00143-5/abstract

A Digital Platform to Optimize Guideline-Directed Heart ... Using wearable home-based monitors and digital scales, the BiovitalsHF platform assembled data regarding patients' status and formulated suggestions regarding ...

3. jacc.org jacc.org/doi/10.1016/j.jacc.2023.04.010

Remote Monitoring for Heart Failure Management at Home Early telemonitoring of weights and symptoms did not decrease heart failure hospitalizations but helped identify steps toward effective monitoring programs.

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. academic.oup.com academic.oup.com/ehjdh/article/3/2/284/6582292

Daily ambulatory remote monitoring system for drug ... The BiovitalsHF is a software platform designed to monitor and manage medication for patients with heart failure. The platform comprises a set of clinician ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04191356

Evaluating Mobile Health Tool Use for Capturing Patient ... The BiovitalsHF® mobile app can capture patients' key cardiopulmonary physiological parameters, functional capacity (using activity patterns, including guided ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9708020/

Daily ambulatory remote monitoring system for drug ... BiovitalsHF. The BiovitalsHF is a software platform designed to monitor and manage medication for patients with heart failure. The platform comprises a set of ...

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

Remote, App-Based Intervention Boosts GDMT Use in HFrEF The intervention was safe overall, Desai reported, with 21 total adverse events in patients managed with the BiovitalsHF system and 18 in those ...