RecruitingPhase 4NCT07405944

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


Sponsor

University Medical Centre Ljubljana

Enrollment

60 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vericiguat — a drug that helps relax and widen blood vessels — can help the heart recover (called reverse remodeling) in people with heart failure where the heart's pumping function is reduced. Researchers will track changes in heart structure and function using echocardiography (ultrasound). **You may be eligible if...** - You are 18 years or older - You have stable heart failure with reduced ejection fraction (your heart pumps at 40% or less of normal capacity) - Your condition has been stable for at least 6 months with no hospitalizations or emergency treatment - You have been on standard heart failure medications for at least 3 months **You may NOT be eligible if...** - Your blood pressure is consistently below 100 mmHg or you have dizziness from low blood pressure - You are currently taking nitrates, other guanylate cyclase stimulators, or medications like sildenafil (Viagra) - You have a known allergy to guanylate cyclase stimulators Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVericiguat

Oral soluble guanylate cyclase stimulator administered once daily, initiated at 2.5 mg and up-titrated in approximately 2-week intervals to 5 mg and then 10 mg as tolerated, in addition to guideline-directed medical therapy for heart failure.

DRUGGuideline Directed Medical Therapy for Heart Failure (GDMT)

Standard combination heart failure therapy according to current guidelines (ARNI, beta-blocker, MRA, and SGLT2 inhibitor as tolerated).


Locations(1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

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NCT07405944


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