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Randomized controlled trial of vericiguat in patients with coronary microvascular dysfunction causing stable chest
Cho-Kiu Lo1, Niki Hiu-Yee Ip1, Tsun-Hei Sin1
1Department of Diagnostic Radiology, School of Clinical Medicine, The University of Hong Kong, Hong Kong, China.
Insights
This study investigates if Vericiguat improves myocardial blood flow (MBF) and myocardial perfusion reserve (MPR) in patients with coronary microvascular dysfunction (CMD). Vericiguat may offer a new therapy for chest pain patients with no obstructive coronary artery disease.
Area of Science:
- Cardiology
- Pharmacology
- Medical Imaging
Background:
- Coronary microvascular dysfunction (CMD) causes ischaemia with no obstructive coronary arteries (INOCA) in ~50% of stable chest pain patients, increasing major adverse cardiovascular events (MACE) risk.
- Vericiguat, a soluble guanylate cyclase stimulator, shows potential for improving coronary microvascular circulation.
- Quantitative stress cardiovascular magnetic resonance (CMR) enables precise measurement of stress myocardial blood flow (MBF) and myocardial perfusion reserve (MPR).
Purpose of the Study:
- To evaluate the efficacy of Vericiguat in improving MBF and MPR in patients diagnosed with stable chest pain and INOCA due to CMD.
- To assess Vericiguat's potential as a novel therapeutic agent for CMD.
Main Methods:
- A single-blind, randomized controlled trial (V-COM) involving 94 patients aged 40-80 with stable chest pain and INOCA.
- Participants receive either Vericiguat plus optimal medical therapy or optimal medical therapy alone for 6 months.
- Primary outcome: change in stress MBF and MPR from baseline to 6 months, measured by quantitative stress CMR.
Main Results:
- The study is designed to provide evidence on Vericiguat's impact on myocardial perfusion parameters.
- Changes in six-minute walk distance and Seattle Angina Questionnaire-7 (SAQ-7) scores will be assessed as secondary outcomes.
Conclusions:
- This trial will determine if Vericiguat effectively enhances myocardial perfusion in patients with CMD.
- Findings will inform the potential use of Vericiguat as a new treatment for CMD and related conditions.
Background:
Previous studies have shown that ∼50% of patients with stable chest pain have no obstructive coronary artery disease (CAD), yet remain at higher risk of major adverse cardiovascular events (MACE) compared to patients without chest pain. Coronary microvascular dysfunction (CMD) is a major cause of ischemia with no obstructive coronary arteries (INOCA). While therapies for CMD are lacking, Vericiguat, a soluble guanylate cyclase stimulator, has shown improvement in coronary microvascular circulation in animal studies. Quantitative stress cardiovascular magnetic resonance (CMR) allows the quantification of stress myocardial blood flow (MBF) and myocardial perfusion reserve (MPR). This study aims to conduct a randomized controlled trial to determine if Vericiguat improves MBF and MPR in patients with stable chest pain and INOCA caused by CMD.
Methods/Design:
V-COM is a single-blind, randomized controlled trial. Ninety-four patients aged 40-80 years with recurrent stable chest pain, nonobstructive coronary arteries on recent coronary computed tomography (CT) or invasive angiography, and CMD defined by stress CMR (MPR <2.19 or stress MBF <2.19 mL/g/min) will be recruited across six centers in Hong Kong. Participants will be randomized 1:1 to vericiguat plus optimal medical therapy (intervention) or optimal medical therapy alone (control). Vericiguat will be prescribed once daily for 6 months, starting at 2.5 mg and titrated up to a target dose of 10 mg based on systolic blood pressure and tolerability. CMR (including quantitative stress perfusion) will be performed at baseline and 6 months. The primary outcome is the between-group difference in change in stress MBF and MPR from baseline to 6 months. Secondary outcomes include change in six-minute walk distance and Seattle Angina Questionnaire-7 (SAQ-7) scores.
Discussion:
This study will provide evidence on whether Vericiguat can improve myocardial perfusion in patients with CMD and offer insights into its potential as a novel therapy for CMD.
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