Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07405944

Vericiguat and Reverse Remodeling Indices in Heart Failure

Led by University Medical Centre Ljubljana · Updated on 2026-02-12

60

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

Sponsors

U

University Medical Centre Ljubljana

Lead Sponsor

S

Slovenian Research Agency

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Vericiguat and Reverse Remodeling Indices in Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older who provide written informed consent
  • Stable heart failure with reduced ejection fraction with no worsening in the past 6 months requiring hospitalization or outpatient diuretic treatment
  • Confirmed diagnosis of chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) by echocardiography within 12 months prior to randomization
  • Stable guideline-directed medical therapy for heart failure for at least 3 months before randomization
Not Eligible

You will not qualify if you...

  • Systolic blood pressure below 100 mmHg or symptomatic low blood pressure
  • Current or planned use of long-acting nitrates, soluble guanylate cyclase stimulators, or phosphodiesterase type V inhibitors
  • Known allergy or hypersensitivity to soluble guanylate cyclase stimulators
  • Awaiting heart transplantation or dependent on continuous inotropic therapy
  • Diagnosis of cardiac amyloidosis, sarcoidosis, myocarditis, stress cardiomyopathy, or tachycardic cardiomyopathy
  • Acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months before randomization
  • Use of long-term mechanical circulatory support of the left ventricle
  • Active infection
  • Chronic kidney disease stage 4 or 5
  • Advanced liver failure classified as Child-Pugh B or C

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Medical Centre Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

T

Tine Bajec, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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