Digital Platform Optimization for Heart Failure

(AIM-POWER Trial)

Recruiting at 17 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

Trial Summary

What is the purpose of this trial?

This trial tests a software that helps doctors manage heart failure medications for patients with a specific type of heart failure. The software uses patient health data to recommend medication adjustments, aiming to reduce hospitalizations and deaths.

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 data supports the effectiveness of the treatment BiovitalsHF for heart failure?

The research highlights that heart failure management can be improved through the use of evidence-based therapies and monitoring systems, which reduce hospitalizations and mortality. Although BiovitalsHF is not directly mentioned, similar approaches in heart failure management have shown positive outcomes. ^{1 2 3 4 5}

Is the digital platform for heart failure treatment safe for humans?

The research articles do not provide specific safety data for the digital platform treatment, including BiovitalsHF, for heart failure or other conditions. ^{6 7 8 9 10}

How is the treatment BiovitalsHF different from other heart failure treatments?

BiovitalsHF is unique because it uses a digital platform with artificial intelligence to support patient self-care, allowing patients to manage their heart failure more independently and personalize their treatment. This approach shifts from a one-size-fits-all model to a predictive, preventive, and personalized care strategy, potentially reducing hospitalizations and healthcare costs. ^{11 12 13 14 15}

Research Team

Akshay Desai, MD

Principal Investigator

Brigham and Womens Hospital

Adam Devore, MD

Principal Investigator

Duke Clinical Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

How well are chronic heart failure patients being managed? [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Developing New Treatments for Heart Failure: Focus on the Heart. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of vitamin D on endothelial and ventricular function in chronic heart failure patients: A prospective, randomized, placebo-controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Reappraisal on pharmacological and mechanical treatments of heart failure. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

How Trialists and Pharmaceutical Sponsors Have Failed Us by Thinking That Acute Heart Failure Is a 48-Hour Illness. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Gene therapy to restore electrophysiological function in heart failure. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Current Focus of Heart Failure Clinical Trials. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Evolving therapies for the management of chronic and acute decompensated heart failure. [2021]

11. Switzerland 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. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

Using an Electronic App to Promote Home-Based Self-Care in Older Patients With Heart Failure: Qualitative Study on Patient and Informal Caregiver Challenges. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Improving outpatient care for heart failure through digital innovation: a feasibility study. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Pragmatic randomized trial assessing the impact of digital health technology on quality of life in patients with heart failure: Design, rationale and implementation. [2023]