What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly those optimized by the Biofourmis BiovitalsHFTM platform, include ACE inhibitors, beta-blockers, aldosterone antagonists, and ARNIs. ACE inhibitors can cause cough, high potassium levels, and kidney dysfunction. Beta-blockers may lead to fatigue, slow heart rate, and asthma exacerbation. Aldosterone antagonists can result in high potassium levels and renal impairment. ARNIs may cause low blood pressure, high potassium levels, and renal dysfunction. These side effects are crucial in managing heart failure patients.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of heart failure with reduced ejection fraction (HFrEF), including beta-blockers (e.g., carvedilol, metoprolol succinate), ACE inhibitors (e.g., enalapril, lisinopril), ARBs (e.g., losartan, valsartan), and mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone). Additionally, the FDA has approved the use of sacubitril/valsartan, a combination ARNI (angiotensin receptor-neprilysin inhibitor), which has shown significant benefits in reducing cardiovascular mortality and heart failure hospitalizations. Technologies such as the CardioMEMS™ HF System, which allows for remote monitoring of pulmonary artery pressure, have also been approved to aid in the management of heart failure patients. These treatments and technologies align with the goals of the Biofourmis BiovitalsHFTM platform, which seeks to optimize medication management and improve outcomes for heart failure patients through advanced monitoring and data analysis.

What other types of research exist?

Promising alternatives to the Biofourmis BiovitalsHFTM platform for heart failure patients include: 1) Eko Health's AI-powered stethoscope and ECG monitoring system, which provides real-time cardiac monitoring and integrates with electronic health records. 2) The HeartLogic Heart Failure Diagnostic from Boston Scientific, which uses multiple sensors to predict heart failure events. 3) The myHeart app by Myia Health, which leverages AI to analyze data from various wearable devices and provides personalized health insights. 4) The CardioMEMS HF System by Abbott, an implantable device that monitors pulmonary artery pressure and helps manage heart failure remotely.

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Artificial Intelligence

Digital Platform Optimization for Heart Failure (AIM-POWER Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Heart Failure with Reduced Ejection Fraction (HFrEF) include ACE inhibitors, beta-blockers, and mineralocorticoid receptor antagonists. ACE inhibitors work by blocking the conversion of angiotensin I to angiotensin II, leading to vasodilation and reduced blood pressure, which decreases the heart's workload. Beta-blockers slow the heart rate and reduce blood pressure, improving heart function and reducing the risk of arrhythmias. Mineralocorticoid receptor antagonists help prevent sodium retention and reduce fluid buildup, alleviating symptoms of congestion. These mechanisms are crucial for managing heart failure as they help improve cardiac output, reduce symptoms, and prevent disease progression. The Biofourmis BiovitalsHFTM platform leverages cloud-based technology to optimize the titration of these medications, ensuring patients receive the most effective dosages tailored to their needs, thereby enhancing treatment outcomes and quality of life.

N/A

Waitlist Available

Led By Maulik Majmudar, MD

Research Sponsored by Biofourmis Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of heart failure (left ventricular ejection fraction ≤ 40%

New York Heart Association (NYHA) class II-III at most recent screening assessment

Must not have

Absolute Contraindications to GDMT

Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since BiovitalsHF is a digital platform that recommends medication adjustments rather than a drug itself, direct side effects aren't expected from the technology. However, changes in medication dosages as advised by the platform may lead to typical heart failure medication side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is reduced (ejection fraction ≤ 40%).

Select...

My heart condition allows me to perform light to moderate activities.

Select...

I am taking less than half the recommended dose for my heart failure medication.

Select...

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

Select...

My heart's pumping ability is significantly reduced.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot take standard heart failure medications due to severe side effects or allergies.

Select...

My kidney function is impaired, with high creatinine or potassium, or low eGFR.

Select...

I have severe COPD that is not well-managed.

Select...

My asthma is not well-managed.

Select...

I have trouble making decisions due to my health condition.

Select...

I am currently in hospice or receiving comfort care.

Select...

I am currently on dialysis.

Select...

I have been diagnosed with cirrhosis.

Select...

I have a history of heart issues or am on a transplant list.

Select...

I cannot use smartphone apps by myself.

Select...

I am not proficient in English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

• To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTx to improve guideline-directed medical therapy (GDMT) adoption in subjects with heart failure with reduced ejection fraction (HFrEF) after 90 days of using the platform

Secondary study objectives

Change in biomarkers

GDMT initiation

Quadruple therapy

+4 more

Other study objectives

Change in quality of life and function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Heart Failure with Reduced Ejection Fraction (HFrEF) include ACE inhibitors, beta-blockers, and mineralocorticoid receptor antagonists. ACE inhibitors work by blocking the conversion of angiotensin I to angiotensin II, leading to vasodilation and reduced blood pressure, which decreases the heart's workload. Beta-blockers slow the heart rate and reduce blood pressure, improving heart function and reducing the risk of arrhythmias. Mineralocorticoid receptor antagonists help prevent sodium retention and reduce fluid buildup, alleviating symptoms of congestion. These mechanisms are crucial for managing heart failure as they help improve cardiac output, reduce symptoms, and prevent disease progression. The Biofourmis BiovitalsHFTM platform leverages cloud-based technology to optimize the titration of these medications, ensuring patients receive the most effective dosages tailored to their needs, thereby enhancing treatment outcomes and quality of life.