Status:
ENROLLING_BY_INVITATION
Digital Remote Home Monitoring for Heart Failure
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
American Heart Association
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
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 A...
Detailed Description
Background/Rationale: Guideline-directed medical therapy (GDMT) is a cornerstone of the management of individuals with heart failure with reduced ejection fraction (HFrEF). Patients on optimal heart ...
Eligibility Criteria
Inclusion
- ≥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.
Exclusion
- 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
Key Trial Info
Start Date :
December 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05988749
Start Date
December 13 2024
End Date
December 2 2025
Last Update
December 20 2024
Active Locations (2)
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1
Parkland Health & Hospital System
Dallas, Texas, United States, 75235
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390