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Digital Remote Home Monitoring for Heart Failure (ADHERE-HF Trial)
N/A
Waitlist Available
Led By Nicholas Hendren, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* ≥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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-90; 0-180 days
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Heart Failure
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-90; 0-180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-90; 0-180 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in KCCQ-12 score
Emergency room visits
GDMT score
+3 moreOther study objectives
Patient encounters
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DeviceExperimental Treatment1 Intervention
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.
Group II: Routine CareActive Control1 Intervention
Routine care for heart failure management
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,088 Previous Clinical Trials
1,059,570 Total Patients Enrolled
26 Trials studying Heart Failure
13,602 Patients Enrolled for Heart Failure
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,037 Total Patients Enrolled
33 Trials studying Heart Failure
137,853 Patients Enrolled for Heart Failure
Nicholas Hendren, MDPrincipal InvestigatorUT Southwestern Medical Center