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NCT07505511: VISUALIZE-PRO
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)
EARLY_PHASE1 trial testing Intervention: Visual Adherence Support (VISUALIZE-Pro) in Adherence, Medication in 100 participants. Not yet recruiting.
1 August 2027
Quick facts
| Lead sponsor | University of Giessen |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 March 2026 |
| Primary completion | 1 August 2027 |
| Estimated completion | 1 March 2028 |
Drugs / interventions tested
- Intervention: Visual Adherence Support (VISUALIZE-Pro)
Conditions studied
- Adherence, Medication — all drugs for Adherence, Medication →
- Adherence, Treatment — all drugs for Adherence, Treatment →
- Heart Failure — all drugs for Heart Failure →
Sponsor
University of Giessen
Who can join
18 and older, any sex, with Adherence, Medication or Adherence, Treatment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07505511
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07505511 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Giessen
- Last refreshed: 1 April 2026
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