122 Participants Needed

Digital Platform Optimization for Heart Failure

(AIM-POWER Trial)

Recruiting at 17 trial locations
TB
FS
Overseen ByFaisal Syed, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Biofourmis Inc.
Must be taking: GDMT for HFrEF
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.1112131415

Research Team

AD

Akshay Desai, MD

Principal Investigator

Brigham and Womens Hospital

AD

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.
See 4 more

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.
See 14 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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: ControlActive Control1 Intervention
Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.

Find a Clinic Near You

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

References

How well are chronic heart failure patients being managed? [2007]
Developing New Treatments for Heart Failure: Focus on the Heart. [2018]
Effect of vitamin D on endothelial and ventricular function in chronic heart failure patients: A prospective, randomized, placebo-controlled trial. [2023]
Reappraisal on pharmacological and mechanical treatments of heart failure. [2020]
How Trialists and Pharmaceutical Sponsors Have Failed Us by Thinking That Acute Heart Failure Is a 48-Hour Illness. [2017]
Gene therapy to restore electrophysiological function in heart failure. [2019]
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]
The Current Focus of Heart Failure Clinical Trials. [2019]
Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. [2020]
Evolving therapies for the management of chronic and acute decompensated heart failure. [2021]
Artificial intelligence supported patient self-care in chronic heart failure: a paradigm shift from reactive to predictive, preventive and personalised care. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Impact of Digital Health Technology on Quality of Life in Patients With Heart Failure. [2023]
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]
Improving outpatient care for heart failure through digital innovation: a feasibility study. [2022]
15.United Statespubmed.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]