Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06415227

The Impact of Vericiguat on Microvascular Function in Patients with Documented Vasospastic Angina Pectoris

Vericiguat in Vasospastic Angina

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
55 (estimated)
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Vasospastic angina is increasingly recognized as an important contributor to anginal symptoms in patients with non-obstructive coronary artery disease (ANOCA). Endothelial dysfunction and smooth muscle cell dysfunction are considered elementary in the development of vasospastic angina. As one of many functions, the vascular endothelium regulates local vascular tone, mainly through the vasodilatory effect of endothelium-derived nitric oxide (NO). Vericiguat is a soluble guanylate cyclase (sGC) stimulator and thereby acts directly on the NO signalling pathway from the endothelium towards the vascular smooth muscle cells. As such, Vericiguat potentially has an beneficial therapeutic effect in patients with vasospastic angina.The VIVA study aims to demonstrate the effect of Vericiguat on endothelial function and microvascular vasodilator responses, as well as its tolerability and safety in patients with vasospastic angina as the pathophysiological substrate of ANOCA.

Conditions

Interventions

TypeNameDescription
DRUGVericiguatThe target dose of vericiguat is 10 milligrams once daily, which will be started at 2.5mg once daily and uptitrated every two weeks to reach the target dose. Dose modification will depend on mean sitting systolic blood pressure and the absence of symptoms indicative of hypotension. The intention of the protocol is to reach and maintain the target study drug dose after completion of uptitration. If the dose is temporarily interrupted, then resumption of study drug treatment and continued uptitration will be considered at any subsequent visit when the investigator feels it is medically appropriate. Vericiguat will be taken orally once daily at about the same time.

Timeline

Start date
2025-04-01
Primary completion
2026-06-01
Completion
2026-06-01
First posted
2024-05-16
Last updated
2025-02-21

Source: ClinicalTrials.gov record NCT06415227. Inclusion in this directory is not an endorsement.