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Trial record 1 of 13 for:    Biofourmis
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Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors (AIM-POWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04191330
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Biofourmis Inc.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 27, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. Assessment of the effectiveness of the Biofourmis cloud-based BiovitalsHF DTx for GDMT optimization. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Use of GDMT less than 50% recommended target dose of at least one HF GDMT
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04191330


Contacts
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Contact: Trace Brookins 919.355.8221 trace@biofourmis.com

Locations
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United States, Arkansas
Cardiology and Medicine Clinic Recruiting
Little Rock, Arkansas, United States, 72204
Contact: Joe Hargrove, MD         
United States, California
Preventive Cardiology Recruiting
Mission Hills, California, United States, 91345
Contact: Rodeny Samaan, MD         
ACRC Studies Recruiting
San Diego, California, United States, 92119
Contact: Albert Sharf, MD         
United States, Colorado
South Denver Cardiology Associates Recruiting
Littleton, Colorado, United States, 80120
Contact: Ira Dauber, MD         
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Phillip Lam, MD         
United States, Maryland
Medstar Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Contact: Sandeep Jani, MD         
United States, Mississippi
Jackson Heart Recruiting
Jackson, Mississippi, United States, 39216
Contact: Brett Bennett, MD         
United States, Ohio
Premier Cardiovascular Institute Recruiting
Dayton, Ohio, United States, 45414
Contact: Rajan Krishnamani, MD         
United States, Texas
Austin Heart Recruiting
San Marcos, Texas, United States, 78666
Contact: Faisal Syed, MD         
Sponsors and Collaborators
Biofourmis Inc.
Investigators
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Study Chair: Akshay Desai, MD Brigham and Womens Hospital
Principal Investigator: Adam Devore, MD Duke Clinical Research Institute
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Responsible Party: Biofourmis Inc.
ClinicalTrials.gov Identifier: NCT04191330    
Other Study ID Numbers: BV-EV-HF-1901
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases