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NCT06526988Recruiting

Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure

Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure With Reduced Ejection Fraction: I-I-CAPTAIN-HF

Source: ClinicalTrials.gov · Last updated 13 Jul 2026

Brief summary (registry, in English)

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 recommended doses, patients often experience significant improvements in cardiac function, quality of life, and survival.1,2 However, GDMT underuse occurs for the vast majority of patients with HFrEF. Two recent trials demonstrated improved GDMT prescribing during a clinic visit, each using automated delivery of a patient-centered decision support tool to promote a proactive and holistic approach to prescribing: EPIC-HF (NCT03334188) tested a brief video and checklist document sent to patients just prior to a clinic visit encouraging them to work with their clinicians to make at least 1 positive change to their GDMT; PROMPT-HF (NCT05433220) tested tailored electronic health record (EHR) alerts for GDMT intensification delivered to clinicians during clinic visits. The current I-I-CAPTAIN-HF study aims to broadly implement and test the EPIC-HF patient-facing and PROMPT-HF clinician-facing tools for HFrEF medication intensification at 5 health systems around the country through a pragmatic cluster-randomized implementation-effectiveness trial. This will occur through an initial phase of adaptation of the 2 tools at each health system. Once ready, the 2 tools will be tested using a 2x2 randomization at the clinician-level. In parallel, formal assessment of the implementation of EPIC-HF and PROMPT-HF will work to understand the most effective means of intervention design and delivery, as well as adaptations due to contextual factors to optimize use.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
2200 (estimated)
First submitted
18 Jul 2024
Start date
6 Mar 2025
Primary completion date
1 Sept 2028
Lead sponsor
University of Colorado, Denver
NCT number
NCT06526988

What you commit to

  • Study type: Interventional
  • Planned participants: 2200
  • From 6 Mar 2025 to the primary completion date, 1 Sept 2028
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Under evaluation for or listed for transplant (or s/p transplant)

Lab values

  • Glomerular filtration rate (GFR) less than 20 or on dialysis

Other

  • Patient:
  • Has a left ventricular assist device
  • On hospice care
  • Preferred language neither English or Spanish

Who the study is looking for

  • 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 10 patients with heart failure with reduced ejection fraction (HFrEF)
    • Patient:
  • Age \> 18 years
  • LVEF \</=40% on most recent cardiology imaging study
  • Has a new or return clinic visit with an enrolled clinician within the next 7 days
  • Is missing at least one of the four classes of medications and does not have an allergy to that class: (1) beta blockers, (2) angiotensin receptor-neprilysin inhibitor, (3) aldosterone receptor antagonists, (4) sodium-glucose co-transporter

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
Yale University
Coordinator of this site? Confirm its status
New HavenUnited StatesRecruiting
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
Sutter Health
Coordinator of this site? Confirm its status
Walnut CreekUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.