Vericiguat and Reverse Remodeling Indices in Heart Failure

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Centre Ljubljana

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Medical Centre Ljubljana

Lead sponsor

Slovenian Research Agency

Collaborator