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โ† Trials
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Vericiguat and Reverse Remodeling Indices in Heart Failure

RecruitingPhase 4Ages 18 Years - anyAllUniversity Medical Centre Ljubljana
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In plain words

What the trial is, and whether it could suit you

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, incl

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Written informed consent from an adult patient (โ‰ฅ 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.
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What it tests

  • Vericiguat
  • Guideline Directed Medical Therapy for Heart Failure (GDMT)
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Where

4 sites
Division of Internal Medicine, Izola General Hospital
Izola, Slovenia
Clinical Department of Vascular Diseases, University Medical Centre Ljubljana
Ljubljana, Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia
University Department of Cardiology and Angiology, University Medical Centre Maribor
Maribor, Slovenia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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