AzTrials
AzTrials

Heart FailureAIM-POWERNCT04191330

Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors

A study testing BiovitalsHF in people with Heart Failure, run by Biofourmis Inc. at 14 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The goal of this real-world, multi-center, randomized, outpatient study is to assess the effectiveness of the Biofourmis cloud based BiovitalsHF platform to recommend optimal titration of Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) subjects. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Heart Failure
What is being tested?
BiovitalsHF
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
14 sitesUnited States
Study dates
27 Jan 2020to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects are eligible to be included in the study only if all the following criteria apply:
  • Written informed consent must be obtained before any assessment is performed
  • Age ≥ 22 years at signing of informed consent
  • Diagnosis of heart failure with left ventricular ejection fraction ≤ 40%, EF can be assessed by any validated method, but assessment must have occurred within the last year.
  • HFrEF patient not on optimal GDMT defined as:
  • Participant not on optimal GDMT for HFrEF per investigator judgement. This would include patients ranging from no treatments for HFrEF to a patient on multiple GDMTs for HFrEF but with at least 1 medication at 50% or less than target dose.

Who cannot join

  • Subjects are excluded from the study if any of the following criteria apply:
  • Therapy related
  • Absolute contraindications to HF GDMT Disease related
  • Heart failure hospitalization in the past 28 days.
  • Baseline creatinine > 2 mg/dl or potassium level at baseline, ≥5 mEq/L or eGFR <30 mL/min/1.73 m2
  • Receiving dialysis at screening
Show all 22Show fewer
  • Baseline systolic blood pressure <100 mmHg
  • History of heart transplant or on transplant list
  • Current or planned left ventricular assist device Comorbidity or other medical conditions
  • Uncontrolled asthma
  • Active wheezing on physical exam
  • Uncontrolled severe COPD
  • Diagnosed with cirrhosis
  • Currently being treated for active malignancy and life expectancy is less than one year
  • Currently receiving hospice or comfort care Prior or concurrent clinical study experience
  • Currently participating or receiving treatment in an investigational device or investigational drug study while participating in this study Other General Exclusions
  • Subject unable to independently navigate and operate smartphone applications
  • Subject not proficient with written and spoken English or Spanish
  • Subject determined likely to be non-compliant by physician/HCP
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Biofourmis medical monitor, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • Subject has diminished decision making capability

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Cambridge Medical Trials

    Alexandria, Louisiana, 71301

  • Piedmont Athens Regional Medical Center

    Athens, Georgia, 30306

  • Medstar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Premier Cardiovascular Institute

    Dayton, Ohio, 45414

  • Jackson Heart

    Jackson, Mississippi, 39216

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • University of Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Cardiology and Medicine Clinic

    Little Rock, Arkansas, 72204

  • Baptist Health Louisville Heart Failure Clinic

    Louisville, Kentucky, 40207

  • Rutgers Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Providence St Vincent Medical Center

    Portland, Oregon, 97225

  • Austin Heart

    San Marcos, Texas, 78666

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • St Joseph Mercy

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors

The goal of this real-world, multi-center, randomized, outpatient study is to assess the effectiveness of the Biofourmis cloud based BiovitalsHF platform to recommend optimal titration of Guideline-Directed Medical Therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF) subjects.

Read the detailed description

Patients with heart failure (HF) remain at high risk for hospitalization and death in part due to underuse of guideline directed medical therapy (GDMT). Digital interventions may facilitate rapid initiation, titration and optimization of GDMT but have not been systematically evaluated in randomized control trials. In the AIM-POWER study, we evaluated the safety and efficacy of a novel software medical application, BiovitalsHF, as a strategy to guide remote optimization of GDMT in patients with HF with reduced ejection fraction (HFrEF).

Conditions
Heart Failure
Being tested
BiovitalsHF
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BiovitalsHFDevice

    BiovitalsHFTM is a cloud-based platform that incorporates continuous physiology data from remote vital signs monitoring devices and electronic patient reported outcome (ePRO) monitoring of subjects at-home to support GDMT dose titration for HFrEF patients.

Study groups in NCT04191330
Study groupRoleWhat they receive
ControlNo interventionSubjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.
InterventionExperimentalSubjects 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.
Receives: Device: BiovitalsHF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. • 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

    The primary endpoint will be the between-group difference in the change at 90 days, between the intervention and control arm in heart failure optimal therapy score.

    Heart Failure Optimal Therapy Score: A heart failure optimal therapy score was developed (see Table S9 below) based on clinical practice guidelines, including the 2021 Update to the 2017 ACC expert consensus decision pathway for optimization of heart failure treatment {REF}. One point is awarded for initiating evidence-based BB, MRA, or ARNI and two points for up titrating those classes of medications to 50% or higher target dose. Two points are awarded for initiating SGLT2 inhibitor as there is a single approved dose (and no opportunity for dose titration). Finally, if a patient is not on an ARNI, one point is awarded for ACEi/ARB at 50% or higher target dose. Of note, ARNI patients do not receive points for ACEi/ARB. The maximum possible score is 8 points, and the minimum possible score is 0 points.

    Measured: 90 days

Secondary outcomes (7)

  1. • To assess the effectiveness of the Biofourmis cloud-based BiovitalsHF DTX to improve the composite clinical outcome by calculating the win ratio between treatment and control arm.

    A win ratio [13] will be used to analyze the composite endpoints in the following order of clinical importance:

    • Time to CV death
    • Time to heart failure related hospitalization
    • Improvement in GDMT score
    • Improvement in KCCQ score
    • Reduction on NTproBNP by 30% compared to baseline (TABLE 3)

    Measured: 90 days

  2. • To assess the effectiveness of the Biofourmis cloud based BiovitalsHF DTx to help improve GDMT adoption and on clinical outcomes.

    • The key secondary endpoint will be the percentage of subjects on target dose of GDMT. Comparisons between the control and intervention arm will be based on the CHAMP-HF registry design [4]. At baseline, day 90, and day 180, subjects will be divided into one of four groups according to prescribed dose of GDMT: subjects not receiving medication, subjects treated with <50% target dose, subjects treated with 50 to <100% target dose, and subjects treated with >100% target dose.

    Measured: 90 days

  3. GDMT initiation

    • Initiation of evidence-based beta-blocker, ACEi/ARB/ARNI, MRA or SGLT2 inhibitors including proportion of subjects switching from ACEi/ARB to ARNI

    Measured: 90 days

  4. Quadruple therapy

    • Proportion of subjects on 4 GDMT drug classes

    Measured: 90 days

  5. Time to GDMT optimization

    • Time taken to achieve 50% target dose between control and intervention arms.

    Measured: 90 days

  6. Change in biomarkers

    • Change in NT-pro-BNP

    Measured: 90 days

  7. Safety outcomes

    • Incidence of worsening renal function (i.e., defined as an increase in serum creatinine > 0.5 mg/dl)
    • Incidence of symptomatic postural hypotension (defined as dizziness, lightheadedness, or syncope due to low blood pressure)
    • Objective evidence of hypotension (SBP < 90 mmHg)
    • Incidence of hyperkalemia (i.e., defined K ≥ __5.5 mEq/L)
    • Incidence of angioedema
    • Incidence of severe bradycardia (i.e., defined as an average heart rate < 50 bpm for 12 hours in one day or for 4 contiguous hours)

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start27 Jan 2020
  3. Primary completion14 Jun 2024
  4. Study completion31 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04191330
Sponsor's protocol ID
BV-EV-HF-1901
Acronym
AIM-POWER
Status last verified
Jun 2024
First submitted
5 Dec 2019
Last updated
17 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • DeVore AD, Majmudar M, Etters L, Xie J, Hao C, Lam PH, Hernandez AF, Fonarow GC, Desai AS. Digital Platform to Optimize Guideline-Directed Heart Failure Therapy: Results of the AIM-POWER Trial. Circ Heart Fail. 2026 Feb;19(2):e013231. doi: 10.1161/CIRCHEARTFAILURE.125.013231. Epub 2025 Dec 3.

    PubMed 41332416

Questions about this trial

What is this clinical trial studying?

A study testing BiovitalsHF in people with Heart Failure, run by Biofourmis Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• 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 (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04191330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in