Status:
RECRUITING
Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Yale University
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An increasing number of guideline-directed medical therapies (GDMT) have been developed for patients with chronic heart failure with reduced ejection fraction (HFrEF). When used in combination at reco...
Detailed Description
I-I-CAPTAIN-HF is a multi-site, type-2 hybrid implementation-effectiveness trial conducted at 5 sites: the University of Colorado (central site), Yale University, Northwestern University, University o...
Eligibility Criteria
Inclusion
- Clinician:
- Clinician (MD, PA, NP) who practices in cardiology outpatient clinics
- Regularly sees patients with left ventricular ejection fraction (EF) \</=40%, where their panel of patients over the last year included at least 25 patients with heart failure with reduced ejection fraction (HFrEF)
- Patient:
- Age \> 18 years
- LVEF \</=40% on most recent cardiology imaging study
- Has had a routine cardiology outpatient clinic appointment in the previous 12 months
- Not on all 4 pillars of GDMT at optimal doses: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor/angiotensin converting enzyme inhibitor/angio-tensin receptor blocker, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter
Exclusion
- Patient:
- Has a left ventricular assist device
- Under evaluation for or listed for transplant (or s/p transplant)
- Glomerular filtration rate (GFR) less than 15
- On IV inotropes
- On hospice care
- Non-English or Non-Spanish speaking
Key Trial Info
Start Date :
March 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT06526988
Start Date
March 6 2025
End Date
September 1 2028
Last Update
June 12 2025
Active Locations (5)
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1
Sutter Health
Walnut Creek, California, United States, 94596
2
University of Colorado
Aurora, Colorado, United States, 80045
3
Yale University
New Haven, Connecticut, United States, 06510
4
Northwestern University
Chicago, Illinois, United States, 60611