An Early Phase 1 interventional study of Intervention: Visual Adherence Support (VISUALIZE-Pro) in Adherence, Medication, Adherence, Treatment and Heart Failure, sponsored by University of Giessen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by University of Giessen · Early Phase 1, Interventional, and Treatment
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.
223 studies on the registry are indexed under Medication Adherence; 108 are open to participants now.
This study's planned enrollment of 100 is below the median of 118 across 189 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →University of Giessen is the lead sponsor of 91 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Medication adherence assessed by therapeutic drug monitoring (TDM)
Medication adherence will be objectively assessed using therapeutic drug monitoring (TDM) by measuring serum concentrations of prescribed heart failure medications (or their metabolites) at predefined study visits. Adherence is defined as detectable drug levels within the expected therapeutic range based on dosing information.
Time frame: At predefined study visits (e.g., baseline and follow-up visits up to 3/6months)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Giessen