NCT07405944 Vericiguat and Reverse Remodeling Indices in Heart Failure
| NCT ID | NCT07405944 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Heart Failure With Reduced Ejection Fraction (HFrEF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-11-01 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 tricuspid annular plane systolic excursion (TAPSE)? * 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.
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 ≤ 40%, 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.
Contact & Investigator
Gregor Poglajen, MD, PhD
PRINCIPAL INVESTIGATOR
Advanced Heart Failure and Transplantation Center, Department of Cardiology, University Medical Centre Ljubljana, Ljubljana, Slovenia
Frequently Asked Questions
Who can join the NCT07405944 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Reduced Ejection Fraction (HFrEF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07405944 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07405944 currently recruiting?
Yes, NCT07405944 is actively recruiting participants. Contact the research team at tine.bajec@kclj.si for enrollment information.
Where is the NCT07405944 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07405944 clinical trial?
NCT07405944 is sponsored by University Medical Centre Ljubljana. The principal investigator is Gregor Poglajen, MD, PhD at Advanced Heart Failure and Transplantation Center, Department of Cardiology, University Medical Centre Ljubljana, Ljubljana, Slovenia. The trial plans to enroll 60 participants.
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