Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver

February 23, 2026 updated by: Denver Health and Hospital Authority
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Denver Health and Hospital Authority
        • Contact:
        • Contact:
          • Ryan C Martin, MD, MPH
          • Phone Number: 303-602-3899
        • Principal Investigator:
          • Ryan C Martin, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Intervention arm will receive specialized education materials and dedicated pharmacy visits between provider visits.
Other: Pharmacy follow up
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.
No Intervention: Standard of Care Arm
Standard of care arm will see heart failure providers as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of visits with initiation or intensification of heart failure medications
Time Frame: This will be assessed at each visit up to 3 months after enrollment.
This will be assessed at each visit up to 3 months after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Kansas City Medical Optimization (KCMO) score from baseline.
Time Frame: Calculated at enrollment and at 3 months.
KCMO is calculated by averaging the percent of target doses for each class of GDMT that is not contraindicated in the patient. The value is thus expressed as a percentage ranging from 0 to 100.
Calculated at enrollment and at 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Collaborators

Colorado Clinical & Translational Sciences Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-1425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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