Adherence, MedicationEarly Phase 1VISUALIZE-PRONCT07505511
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)
A Early Phase 1 study testing Intervention: Visual Adherence Support (VISUALIZE-Pro) in people with Adherence, Medication and Adherence, Treatment, run by University of Giessen.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Medication, Adherence, Treatment, Heart Failure
- What is being tested?
- Intervention: Visual Adherence Support (VISUALIZE-Pro)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read more
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
- Being tested
- Intervention: Visual Adherence Support (VISUALIZE-Pro)
- Medical subject headings
- Medication Adherence, Treatment Adherence and Compliance, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention: Visual Adherence Support (VISUALIZE-Pro)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Visual Adherence Support (VISUALIZE-Pro) | Other | 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. Receives: Behavioral: Intervention: Visual Adherence Support (VISUALIZE-Pro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At predefined study visits (e.g., baseline and follow-up visits up to 3/6months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Kruse Johannes, Florian Blachutzik, Andreas Rieth
- Responsible party
- Principal investigator, Jamschid Sedighi, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505511
- Sponsor's protocol ID
- Version 1.0
- Acronym
- VISUALIZE-PRO
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07505511
- Acronym / sponsor ID
- VISUALIZE-PRO / Version 1.0
- Conditions
- Adherence, Medication, Adherence, Treatment, Heart Failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Kruse Johannes, Florian Blachutzik, Andreas Rieth
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention: Visual Adherence Support (VISUALIZE-Pro) | Other | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention: Visual Adherence Support (VISUALIZE-Pro) |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intervention: Visual Adherence Support (VISUALIZE-Pro) in people with Adherence, Medication and Adherence, Treatment, run by University of Giessen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.