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Vericiguat for the Inhibition of Calcific Aortic Valve Stenosis Progression

NCT07715279 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2026-07-21

No results posted yet for this study

Summary

Calcific aortic valve stenosis (CAVS) is a condition in which the aortic valve progressively narrows and stiffens due to calcium deposition, eventually impairing blood flow from the heart to the body. No drug therapy has been proven to slow CAVS progression. Individuals with mild-to-moderate CAVS are managed with periodic monitoring until the stenosis becomes severe, at which point surgical or transcatheter valve replacement is the only treatment option. The goal of this clinical trial is to determine whether vericiguat, an oral soluble guanylate cyclase (sGC) stimulator, can slow the progression of mild-to-moderate CAVS.

The primary questions this study aims to answer are:

Does vericiguat slow the progression of aortic valve calcium accumulation, as measured by the change in aortic valve calcium score from baseline to 24 months, compared to placebo?

The study will compare vericiguat against a placebo (an inactive pill that is identical in appearance but contains no active drug). Both participants and the research team will not know which treatment each participant is receiving throughout the study.

Participants will:

Take vericiguat or placebo orally once daily for 24 months; Begin treatment at 2.5 mg/day and undergo a stepwise dose increase every two weeks to a target dose of 10 mg/day, provided the drug is tolerated; Attend approximately 8 scheduled study visits over two years, during which they will undergo cardiac imaging examinations (transthoracic echocardiography and non-contrast cardiac CT), blood sample collection, physical assessment, and completion of standardized questionnaires on quality of life and heart failure symptoms; Undergo cardiac magnetic resonance imaging (MRI) at the beginning and end of the study, if there are no contraindications.

Approximately 238 participants will be enrolled across roughly 19 hospitals in China.

Conditions

  • Calcific Aortic Valve Disease
  • AORTIC VALVE DISEASES
  • Aortic Valve Stenosis

Interventions

DRUG

Vericiguat (BAY1021189)

Vericiguat 2.5 mg orally once daily, titrated every 2 weeks (2.5 mg → 5 mg → 10 mg) to a target maintenance dose of 10 mg once daily. Total treatment duration: 24 months

DRUG

Placebo

Matching placebo tablets orally once daily, with a dose-titration schedule synchronized to the vericiguat arm to maintain blinding. Placebo tablets are identical to vericiguat tablets (2.5 mg, 5 mg, and 10 mg dose strengths) in size, shape, color, and texture. The same SBP-based dose-adjustment rules are applied. Total treatment duration: 24 months.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2029-10-31
Completion
2029-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715279 on ClinicalTrials.gov