Vericiguat and Reverse Remodeling Indices in Heart Failure
Vericiguat's Effects on Reverse Remodeling Indices: Pathophysiologic Approach to Treatment of Heart Failure With Reduced Ejection Fraction
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- Chronic Heart Failure
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- University Medical Centre Ljubljana
- Enrolment target
- 70
- Started
- 1 November 2025
- Main results due
- 31 July 2027
- Study sites
- 4
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Written informed consent from an adult patient (≥ 18 years old) to participate in the clinical study, * Stable HFrEF defined as no heart failure worsening in the 6 months before randomization that required hospitalization or outpatient diuretic treatment, * Confirmed diagnosis of chronic heart failure with reduced ejection fraction (LVEF \< 50%, confirmed by echocardiography) within 12 months before randomization, * Stable GDMT for HFrEF for at least 3 months prior to randomisation. Exclusion Criteria: * Systolic blood pressure \< 100 mmHg or symptomatic hypotension, * Current or planned use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type V inhibitors, * Known allergy/hypersensitivity to soluble guanylate cyclase stimulators, * Awaiting heart transplantation or dependence on continuous inotropic therapy * Cardiac amyloidosis, sarcoidosis, myocarditis, stress cardiomyopathy, or tachycardic cardiomyopathy, * Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention in the past three months before randomisation, * Long-term mechanical circulatory support of the left ventricle, * Active infection, * Chronic kidney disease stage 4 or 5, and * Advanced liver failure classified as Child-Pugh B or C.
What this study is about
In the sponsor’s own words, from the registry.
The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy.
The main questions are:
* Does vericiguat improve right ventricular systolic function, measured by fractional area change (FAC)? * Does vericiguat favourably influence myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance? * Do genetic and oxidative stress profiles modify treatment response? Researchers will compare a group receiving vericiguat plus usual care with a group receiving usual care alone to assess structural, functional, and biomarker changes over 12 months.
Participants will:
* Have blood drawn at baseline and follow-up visits for biomarker, metabolomic, genetic, transcriptomic, and hematologic analyses, including platelet function testing * Perform oral glucose tolerance tests (OGTT) to assess insulin resistance * Undergo echocardiography, cardiac magnetic resonance imaging, and cardiac scintigraphy to evaluate heart structure, function, and perfusion * Attend follow-up visits at 1, 3, 6, and 12 months Open-label extension: After the 12-month randomized phase, participants originally assigned to usual care will be offered open-label vericiguat and followed for an additional 12 months. This exploratory extension will reassess study outcomes to evaluate the consistency and magnitude of response to vericiguat in the prior control cohort.
Study sites(4)
Division of Internal Medicine, Izola General Hospital
Izola, Slovenia
Recruiting
Clinical Department of Vascular Diseases, University Medical Centre Ljubljana
Ljubljana, Slovenia
Recruiting
University Medical Centre Ljubljana
Ljubljana, Slovenia
Recruiting
University Department of Cardiology and Angiology, University Medical Centre Maribor
Maribor, Slovenia
Recruiting
Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07405944. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me