NCT06526988 Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure
| NCT ID | NCT06526988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Heart Failure With Reduced Ejection Fraction |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,200 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,200 participants in total. It began in 2025-03-06 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patient: * Has a left ventricular assist device * Under evaluation for or listed for transplant (or s/p transplant) * Glomerular filtration rate (GFR) less than 20 or on dialysis * On hospice care * Preferred language neither English or Spanish
Contact & Investigator
Larry A Allen, MD, MHS
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06526988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06526988 currently recruiting?
Yes, NCT06526988 is actively recruiting participants. Contact the research team at larry.allen@cuanschutz.edu for enrollment information.
Where is the NCT06526988 trial being conducted?
This trial is being conducted at Walnut Creek, United States, Aurora, United States, New Haven, United States, Chicago, United States and 1 additional location.
Who is sponsoring the NCT06526988 clinical trial?
NCT06526988 is sponsored by University of Colorado, Denver. The principal investigator is Larry A Allen, MD, MHS at University of Colorado, Denver. The trial plans to enroll 2,200 participants.
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