NCT07435662 · Denver Health and Hospital Authority
Optimizing Heart Failure Therapies Among Patients With Limited Access in Denver
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- Inability to consent
- Non-English or non-Spanish speaking
Where
- Denver, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations