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

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ClinicalTrials.gov Identifier: NCT04191330
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : March 24, 2021
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 Clinical Decision Support 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® Clinical Decision Support 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 : July 2021
Estimated Study Completion Date : October 2021

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, Clinical Decision Support 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. Difference in percent of subjects at 50% target GDMT dose [ Time Frame: 90 days ]
    The primary endpoint will be the difference, at 90 days, between the intervention and control arm in the percentage of subjects on beta-blocker, ACEi/ARB/ or ARNI, and MRA at 50% target dose


Secondary Outcome Measures :
  1. Difference in percent of subjects at target GDMT dose [ Time Frame: 90 days ]
    The key secondary endpoint will be the percentage of subjects on target dose of GDMT

  2. Change in NT-proBNP [ Time Frame: 90 and 365 days ]
    Change in NT-proBNP, from baseline, between the control and intervention arms at day 90 and 365.

  3. HF Hospitalizations [ Time Frame: 90 days ]
    The difference of HF Hospitalizations between the control and intervention arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of heart failure (left ventricular ejection fraction ≤ 40%, assessed by Echocardiogram, Cardiac MRI, Cardiac CT, or Nuclear Perfusion) within the past year
  • New York Heart Association (NYHA) class II-III at most recent screening assessment
  • HFrEF patients not on GDMT or HFrEF patients who are on the following:

    1. Less than or equal to metoprolol succinate 50 mg daily
    2. Less than or equal to carvedilol 6.25 mg po twice daily
    3. Less than or equal to bisoprolol 2.5 mg po daily
    4. Less than or equal to lisinopril 20 mg po daily (or equivalent ACEi dose)
    5. Less than or equal to valsartan 160 mg po daily (or equivalent ARB dose)
    6. Less than or equal to sacubitril/valsartan 24/26 mg po twice daily
    7. Any combination of 1 - 3 and any combination of 4 - 6

Exclusion Criteria:

  • Contraindications to GDMT
  • Current treatment with beta-blocker dose greater than either metoprolol 50 mg daily, carvedilol 6.25 mg po twice daily, or bisoprolol 2.5 mg po daily
  • Current treatment with ACEi equivalent to greater than lisinopril 20 mg po daily
  • Current treatment with ARB equivalent to greater than valsartan 160 mg po daily
  • Current treatment with MRA
  • Current treatment at or above the 50% recommended dose level of any single or combination of GDMT recommended medications
  • Subjects who are concurrently taking any combination of ACEi, ARB, or ARNI
  • Subjects who are taking more than one beta-blocker
  • 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
  • Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) ³ 180 mm Hg or diastolic BP (DBP) ³ 110 mm Hg
  • Baseline systolic blood pressure <100 mmHg
  • Baseline resting heart rate <65 bpm
  • History of angioedema
  • Sick sinus syndrome
  • IDDM
  • History of or on transplant list
  • Left ventricular assist device
  • Implantable cardioverter-defibrillator (ICD)
  • Permanent Pacemaker (PPM)
  • Asthma
  • Active wheezing on physical exam
  • Severe COPD
  • Home oxygen use
  • Diagnosed cirrhosis or moderate hepatic impairment
  • Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
  • Hospitalization for any reason other than heart failure within the 30 days prior to randomization
  • Currently receiving hospice or comfort care
  • Currently participating or receiving treatment in an investigational device or drug study or any other investigational procedures while participating in this study or having participated in a study less than 30 days prior to screening are excluded
  • Subject unable to connect to internet from their domicile (either via cellular, land-line phone or cable service)
  • Subject unable to independently navigate and operate smartphone applications
  • Subject not proficient with written and spoken English
  • 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, Alabama
Appalachian Cardiovascular Associates Recruiting
Fort Payne, Alabama, United States, 35967
Contact: Sanjeev Saxena, MD    256-997-9200      
Sponsors and Collaborators
Biofourmis Inc.
Investigators
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Study Chair: Akshay Desai, MD Brigham and Womens Hospital
Principal Investigator: Maulik Majmudar, MD Biofourmis Inc.
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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: March 24, 2021
Last Verified: March 2021
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