Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07435662

Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health and Hospital Authority

Denver, Colorado, 80220, United States

Location status: Recruiting

Location contact

Ryan C Martin, MD, MPH

CONTACT

[email protected]

303-602-3899

Ryan C Martin, MD, MPH

CONTACT

303-602-3899

Ryan C Martin, MD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ryan C Martin, MD, MPH

CONTACT

[email protected]

303-602-3899

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • Colorado Clinical & Translational Sciences Institute

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.