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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention: Visual Adherence Support (VISUALIZE-Pro).
- Who it may be relevant to
- Registry conditions: Adherence, Medication, Adherence, Treatment, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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-repo
Primary outcome measures
- Medication adherence assessed by therapeutic drug monitoring (TDM) [Time frame: At predefined study visits (e.g., baseline and follow-up visits up to 3/6months)]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Diagnosis of heart failure with reduced ejection fraction (HFrEF) (left ventricular ejection fraction ≤40%)
- Indication for guideline-directed medical therapy (GDMT) for heart failure
- Stable clinical condition at the time of enrollment
- Ability to understand the study procedures and provide written informed consent
Exclusion criteria
- Acute decompensated heart failure requiring immediate hospitalization
- Severe cognitive impairment or inability to understand study-related information
- Life expectancy <6 months due to non-cardiac comorbidities
- Participation in another interventional clinical trial that may interfere with this study
- Contraindications to prescribed heart failure medications
- Any condition that, in the investigator's judgment, precludes safe participation in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07505511 · Version 1.0