Digital Remote Home Monitoring for Heart Failure

NCT05988749 | Terminated

• 1 other identifier: STU-2023-0529
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

We will enroll 150 adult participants with systolic heart failure into the ADHERE-HF trial. The study will randomize participants in a 1:2 fashion to usual care or usual care plus the American Heart Association's Digital Solution for 90 days. This wearable device and careplan package is hypothesized to improve rates of guideline directed heart failure medical care for participants.

Conditions

Heart Failure, Systolic

Keywords

remote home monitoring; heart failure; guideline directed medical therapy

Outcome Measures

Primary Outcomes (1)

• GDMT score

  Change in GDMT score from between the intervention and control arm.

  0-90 days

Secondary Outcomes (6)

• Hospitalized days

  0-90 days; 0-180 days

• Emergency room visits

  0-90 days; 0-180 days

• GDMT score

  0-180 days

• Change in KCCQ-12 score

  day 0-90 and 0-180

• Visual analog score change

  day 0-90

Other Outcomes (1)

• Patient encounters

  0-90; 0-180 days

Study Arms (2)

Device

EXPERIMENTAL

Participants will receive usual care or usual care plus the American Heart Association's Digital Solution in patients with HFrEF. The Solution is a combination of the AHA/CHTI HF CarePlans and Education Content, delivered through and combined with the Biofourmis Platform.

Other: Biofourmis Digital Platform

Routine Care

NO INTERVENTION

Routine care for heart failure management

Interventions

Biofourmis Digital Platform OTHER

The intervention is a combination of the American Heart Association's Digital Heart Failure CarePlans and Education Content, delivered through and combined with the Biofourmis Platform. Patients enrolled in this arm will wear the device for 90 days and provide data to the participant's care team.

Also known as: American Heart Association's Digital Heart Failure CarePlans and Education Content

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18-year-old adults with a clinical diagnosis of heart failure AND a left ventricular ejection fraction ≤40% by transthoracic echocardiogram or cardiac MRI within 12 months prior to enrollment.

You may not qualify if:

• Patients who are pregnant.
• Patients who do not have a smartphone or access to the Internet
• Prisoners or refugees.
• Patients who are homeless or have unstable housing.
• Unable or unwilling to consent or use study related materials.
• On-going cocaine, methamphetamine, opioid, alcohol, or other illicit substance abuse as determined by the study PI.
• Not fluent in English or Spanish.
• Students or trainees at UT-Southwestern or Parkland Health System.
• Enrolled or considering hospice.
• Recent or home inotropic therapy, or heart transplant evaluation.
• Survival anticipated \<6 months.
• End-stage renal disease, receiving dialysis or eGFR ≤30 mL/min/1.73m2
• Non-Texas resident

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (2)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nicholas Hendren, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: Patients will be randomized in a 1:2 fashion to usual care versus usual care plus the American Heart Association's Digital Solution by dice roll.

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: December 13, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)