Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver

NCT07435662 | Recruiting

• 1 other identifier: 25-1425
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Numerous pharmacotherapies have been proven to reduce mortality and hospitalization rates for heart failure with reduced ejection fraction (HFrEF) patients. However, these are underutilized clinically, preventing realization of proven benefits. Simplified patient education tools and multidisciplinary teams including pharmacists have been used to improve medication optimization but in predominantly private payer groups. This study will translate these evidence-based interventions to patients with limited access to care. In this randomized, prospective study, patients with HFrEF at a local hospital dedicated to care for participants with limited access will receive either pharmacist-directed medication adjustment visits with patient education materials or standard of care. This study will assess the hypothesis that the implementation of the intervention is feasible in this population, as demonstrated by the number of visits and proportion of visits with medication adjustments. Further, medication dosing in each arm will be evaluated via the Kansas City Medication Optimization (KCMO) score, which will average the percentage of maximal doses of appropriate HFrEF medication classes a patient is on. The change in KCMO scores over the course of the pilot in the two arms will then be compared to assess the hypothesis that the intervention will better increase patients' KCMO scores than the standard of care. The findings of this study will help address knowledge gaps in the care of patients not well represented previously in the literature. This proposal addresses the translational science roadblock of recruitment and engagement of participants with limited access to care.

Conditions

Heart Failure; Medication Optimization

Keywords

heart failure; limited access to care

Outcome Measures

Primary Outcomes (1)

• Proportion of visits with initiation or intensification of heart failure medications

  This will be assessed at each visit up to 3 months after enrollment.

Secondary Outcomes (1)

• Change in Kansas City Medical Optimization (KCMO) score from baseline.

  Calculated at enrollment and at 3 months.

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention arm will receive specialized education materials and dedicated pharmacy visits between provider visits.

Other: Pharmacy follow up

Standard of Care Arm

NO INTERVENTION

Standard of care arm will see heart failure providers as usual

Interventions

Pharmacy follow up OTHER

Patients in the intervention will have additional follow ups with pharmacy between heart failure provider visits. They will also receive specialized simple patient education re: heart failure meds.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of HFrEF (EF ≤ 40%)
• Receiving care within DHHA system

You may not qualify if:

• Estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73 m² or receiving dialysis.
• Cirrhosis
• Inability to consent
• Non-English or non-Spanish speaking

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Colorado Clinical & Translational Sciences Institute: collaborator

Study Sites (1)

Denver Health and Hospital Authority

Denver, Colorado, 80220, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Ryan C Martin, MD, MPH

CONTACT

303-602-3899; Ryan.Martin2@dhha.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: February 27, 2026
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: July 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)