AIM-POWER: Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors

Sponsor

Biofourmis Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04191330

Collaborator

(none)

282

Enrollment

Locations

Arms

44.1

Anticipated Duration (Months)

31.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: BiovitalsHF	N/A

Detailed Description

The purpose of this study is to assess the effectiveness of the cloud-based BiovitalsHF® platform to manage initiation and titration of GDMT outside of normal or traditional clinical encounters. The effectives comparison will be to the current standard of care for HF used in the respective clinical sites.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

282 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 27, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.
Experimental: 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.	Device: BiovitalsHF 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.

Arm

Intervention/Treatment

No Intervention: Control

Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.

Experimental: 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.

Device: BiovitalsHF

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.

Outcome Measures

Primary Outcome Measures

Assessment of the effectiveness of the Biofourmis cloud-based BiovitalsHF DTx for GDMT optimization. [90 days]
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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of heart failure (left ventricular ejection fraction ≤ 40%
New York Heart Association (NYHA) class II-III at most recent screening assessment
HFrEF patients not on GDMT defined as:

Use of GDMT less than 50% recommended target dose of at least one HF GDMT
Use of GDMT at 50% to <100% recommended target doses of two HF GDMTs

Exclusion Criteria:

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
Receiving dialysis at screening
Baseline systolic blood pressure <100 mmHg
History of heart or on transplant list
Current or planned Left ventricular assist device
Currently receiving hospice or comfort care
Currently participating or receiving treatment in an investigational device or investigational drug study while participating in this study
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology and Medicine Clinic	Little Rock	Arkansas	United States	72204
2	Preventive Cardiology	Mission Hills	California	United States	91345
3	ACRC Studies	San Diego	California	United States	92119
4	South Denver Cardiology Associates	Littleton	Colorado	United States	80120
5	Medstar Washington Hospital Center	Washington	District of Columbia	United States	20010
6	Medstar Union Memorial Hospital	Baltimore	Maryland	United States	21218
7	Jackson Heart	Jackson	Mississippi	United States	39216
8	Premier Cardiovascular Institute	Dayton	Ohio	United States	45414
9	Austin Heart	San Marcos	Texas	United States	78666

Sponsors and Collaborators

Biofourmis Inc.

Investigators

Study Chair: Akshay Desai, MD, Brigham and Womens Hospital
Principal Investigator: Adam Devore, MD, Duke Clinical Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biofourmis Inc.

ClinicalTrials.gov Identifier:

NCT04191330

Other Study ID Numbers:

BV-EV-HF-1901

First Posted:

Dec 9, 2019

Last Update Posted:

Jul 26, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jul 26, 2022