NCT07505511

Visualization of the Effects of Guideline-directed Medical Therapy (GDMT) on Improving Adherence and Quality of Life in Heart Failure With Reduced Ejection Fraction (HFrEF)

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure with reduced ejection fraction (HFrEF) remains a major public health challenge with substantial morbidity and mortality despite the availability of effective guideline-directed medical therapy (GDMT). Although four major drug classes have been shown to significantly improve survival and reduce hospitalizations, real-world implementation remains suboptimal. In addition to underutilization by healthcare providers, poor medication adherence among patients-reported to range between 29% and 63%-represents a critical barrier to achieving optimal therapeutic benefit. The Visualize-Pro study is a prospective, exploratory pilot study designed to evaluate a simple, patient-centered intervention aimed at improving medication adherence in patients with HFrEF. The intervention consists of patient-friendly graphical visualizations illustrating the survival benefits and risk reduction associated with optimal heart failure therapy. These materials are designed to enhance patient understanding, motivation, and engagement with prescribed treatments. To objectively assess medication adherence, this study incorporates therapeutic drug monitoring (TDM) as a gold standard method, in addition to established patient-reported outcome measures such as quality of life and adherence questionnaires. Blood samples will be collected at predefined study visits, and drug levels (or their metabolites) will be analyzed in collaboration with a specialized laboratory to quantify adherence. Participants will be followed over a predefined study period with serial assessments at scheduled visits. The primary objective is to evaluate the feasibility and preliminary effectiveness of the intervention in improving medication adherence. Secondary objectives include assessing changes in patient-reported outcomes and exploring associations between adherence and clinical parameters. As a pilot study, the results are intended to inform the design of a future large-scale, multicenter trial. Ultimately, this approach aims to provide a scalable and low-threshold strategy to improve adherence to life-saving therapies in heart failure, thereby contributing to reduced morbidity and mortality in this high-risk population.

Conditions

• Adherence, Medication
• Adherence, Treatment
• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	Intervention: Visual Adherence Support (VISUALIZE-Pro)	Participants receive a patient-centered adherence intervention using graphical visualizations to illustrate the survival benefits and risk reduction associated with guideline-directed medical therapy (GDMT) for heart failure. The VISUALIZE-Pro approach aims to improve patients' understanding of their treatment, enhance motivation, and promote medication adherence. Adherence is objectively assessed using therapeutic drug monitoring (TDM) at predefined study visits and complemented by patient-reported outcomes and clinical assessments.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-08-01
• Completion: 2028-03-01
• First posted: 2026-04-01
• Last updated: 2026-04-01