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Published on: February 3, 2021
Rationale and design of the vericiguat in vasospastic angina (ViVA) trial: A double-blind placebo-controlled
H F Namba1, E A M de Jong2, C K M Boerhout3
1Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Insights
Vericiguat may reduce coronary vasospasm episodes in patients with angina and no obstructive coronary arteries (ANOCA) by restoring vascular balance. The ViVA trial will assess its efficacy, safety, and impact on endothelial function and quality of life.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
Background:
- Coronary vasospasm is common in angina with no obstructive coronary arteries (ANOCA).
- Endothelial dysfunction and vascular smooth muscle cell hyperreactivity disrupt vasodilation/vasoconstriction balance.
- Nitric oxide (NO) signaling via soluble guanylate cyclase (sGC) is key for vasodilation.
Purpose of the Study:
- To evaluate the efficacy of vericiguat in reducing coronary vasospasm episodes in ANOCA patients.
- To assess vericiguat's impact on endothelial function and microvascular vasodilator responses.
- To determine the tolerability and safety of vericiguat in this patient population.
Main Methods:
- The Vericiguat in Vasospastic Angina (ViVA) trial (ClinicalTrials.gov ID NCT06415227) is a prospective study.
- Patients with coronary vasospasm as the cause of ANOCA will be enrolled.
- The study will measure changes in endothelial function, angina symptoms, and quality of life.
Main Results:
- This section will report findings from the ViVA trial upon completion.
- Results will focus on the primary and secondary endpoints related to vericiguat's effects.
Conclusions:
- Hypothesizes that vericiguat can restore vascular balance and reduce coronary spasm.
- The ViVA trial will provide crucial data on vericiguat's role in managing ANOCA.
- Findings may support vericiguat as a novel therapeutic option for ANOCA patients.
Background:
Coronary vasospasm is highly prevalent in patients with angina and no obstructive coronary arteries (ANOCA). In the pathophysiology of coronary vasospasm, endothelial dysfunction and vascular smooth muscle cell hyperreactivity may cause an imbalance between vasodilation and vasoconstriction. Within this pathophysiology, nitric oxide is crucial. Nitric oxide activates soluble guanylate cyclase, which through the nitric oxide-soluble guanylate cyclase-cyclic guanosine monophosphate pathway, reduces intracellular calcium levels in vascular smooth muscle cells, resulting in vasodilation. sGC stimulators, such as vericiguat, enhance the sensitivity of soluble guanylate cyclase to nitric oxide. Vericiguat was shown to be well tolerated, safe, and clinically effective in both heart failure patients as well as in patients with coronary artery disease. We hypothesize that vericiguat restores the balance between vasodilation and vasoconstriction and thereby reduces coronary spasm episodes in ANOCA patients.
Methods:
In the Vericiguat in Vasospastic Angina trial, we will assess the impact of vericiguat on endothelial function and microvascular vasodilator responses, angina and quality of life. Additionally, we will evaluate the tolerability and safety of vericiguat in patients with coronary vasospasm as the pathophysiological substrate of ANOCA. 50 patients will be included in the trial, and will be randomized in a 1:1 ratio to placebo treatment first, followed by vericiguat treatment, or vericiguat treatment first, followed by placebo treatment.
Trial Registration:
The Vericiguat in Vasospastic Angina trial is registered at ClinicalTrials.gov ID NCT06415227.
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