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Vericiguat and Reverse Remodeling Indices in Heart Failure

Study acronym: VERI-PATH
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Enrollment increased: 60 → 70 participants
    • Eligibility criteria revised
    • Study description shortened, about 2 words
  2. Minor Trial sites expanded: 1 → 4 locations
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 5 of 11 entries
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07405944
Lead Sponsor University Medical Centre Ljubljana
Collaborators: Slovenian Research Agency
Conditions
(from sponsor)
Heart Failure With Reduced Ejection Fraction (HFrEF), Chronic Heart Failure
Related terms Fibrosis, Inflammation, Insulin Resistance
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov