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Artificial Intelligence
Digital Platform Optimization for Heart Failure (AIM-POWER Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
AIM-POWER Trial Summary
This trial will test how well a cloud-based platform can recommend GDMT dosage for HFrEF patients.
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.Check my eligibility
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.See study design
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.
AIM-POWER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
AIM-POWER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of the effectiveness of the Biofourmis cloud-based BiovitalsHF™ DTx for GDMT optimization.
Secondary outcome measures
Assessment of the effectiveness of the Biofourmis cloud-based BiovitalsHF™ Dtx to improve clinical outcome.
To assess the effectiveness of the Biofourmis cloud based BiovitalsHF™ DTx to help improve GDMT
AIM-POWER 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.
Find a Location
Who is running the clinical trial?
Biofourmis Inc.Lead Sponsor
4 Previous Clinical Trials
1,600 Total Patients Enrolled
3 Trials studying Heart Failure
1,500 Patients Enrolled for Heart Failure
Maulik Majmudar, MDPrincipal InvestigatorBiofourmis Inc.
Akshay Desai, MDStudy ChairBrigham and Womens Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You currently have or are planning to have a left ventricular assist device.My asthma is not well-managed.I was diagnosed with heart failure with reduced ejection fraction over 3 months ago.My kidney function is impaired, with high creatinine or potassium, or low eGFR.I cannot use smartphone apps by myself.My heart's pumping ability is significantly reduced.I am taking less than half the recommended dose for my heart failure medication.My heart's pumping ability is reduced (ejection fraction ≤ 40%).I have trouble making decisions due to my health condition.My heart condition allows me to perform light to moderate activities.I have severe COPD that is not well-managed.I am currently in hospice or receiving comfort care.I cannot take standard heart failure medications due to severe side effects or allergies.I am currently on dialysis.Your blood pressure is lower than 100 mmHg before starting the study.I have been diagnosed with cirrhosis.I am not proficient in English or Spanish.I have a history of heart issues or am on a transplant list.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this medical research project?
"According to the clinicaltrials.gov information, this medical trial presently requires more study participants. It was initially posted on January 27th 2020 and has been recently updated on July 21st 2022."
Answered by AI
Are participants in this trial allowed to be over the age of twenty?
"Complying with the study's predetermined eligibility criteria, participants must be between 22 and 80 years old."
Answered by AI
Are there any Canadian medical facilities currently testing this protocol?
"This research is being conducted at Premier Cardiovascular Institute in Dayton, Ohio; Cardiology and Medicine Clinic in Little Rock, Arkansas; ACRC Studies in San Diego, Texas; and 10 additional centres."
Answered by AI
How many individuals are eligible for this investigation?
"To properly execute this trial, a total of 282 individuals meeting the study's criteria are necessary. Biofourmis Inc., the sponsor will be running it from various sites with Premier Cardiovascular Institute in Dayton and Cardiology and Medicine Clinic in Little Rock being two among them."
Answered by AI
To whom is this clinical research open?
"This medical trial seeks 282 participants, aged between 22 and 80 that suffer from heart failure. In addition to these criteria, patients must have a left ventricular ejection fraction of 40% or less, be classified as NYHA Class II-III in the most recent screening assessment, and take doses of GDMT below 50%, with two medicines being taken at levels between 50-100%."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
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