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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · May 10, 2024

Keywords

ClinConnect Summary

This clinical trial, called the VIVA study, is investigating how a medication named Vericiguat can help improve blood vessel function in patients with a condition called vasospastic angina. This condition causes chest pain due to spasms in the coronary arteries, which can occur even without blockages. The study aims to see if Vericiguat can enhance the way blood vessels respond and relax, potentially providing relief to those who experience recurrent chest pain despite current treatments.

To participate, individuals must be over 18 years old and have ongoing symptoms of chest pain related to exertion or episodes of pain at rest, occurring at least once a week. They should have confirmed vasospastic angina, which means their condition has been clearly identified through specific tests. However, patients with certain heart issues or other serious health conditions may not be eligible for this study. If you join, you will receive the study medication and be monitored for how well it works and its safety. This trial is not yet recruiting participants, so there will be more information available soon for those who are interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 years
• • Recurrent angina symptoms provoked by exercise and/or repeated attacks of angina at rest at least once weekly despite current medical treatment.
• • Absence of (co-existing) flow-limiting coronary artery stenosis (as defined by any coronary artery diameter reduction \>50%, or fractional flow reserve≤0.80, or instantaneous wave-free ratio/resting full cycle ratio ≤0.89).
• • Unambiguous epicardial and/or microvascular coronary vasospasm according to the COVADIS criteria, documented by invasive acetylcholine provocation testing.
• • A female participant is eligible to participate if at least one of the following conditions applies: Women with a confirmed post-menopausal state (defined as amenorrhea for at least 12 months without an alternative medical cause); or premenopausal women with documented hysterectomy, documented bilateral salpingectomy or documented bilateral oophorectomy; or for women of childbearing potential: Negative highly sensitive urine or serum pregnancy test within 24 hours the first dose of study intervention and practicing a highly effective birth control method (failure rate of less than 1%) during the study intervention period / and for at least one month after the last dose of study intervention: progestogen-only subdermal contraceptive implant, intrauterine system (progestin releasing intrauterine device), non-hormonal intrauterine device, bilateral tubal occlusion, azoospermic partner (vasectomized or secondary to medical cause) or heterosexual abstinence.
• Exclusion Criteria:
• • Impaired left ventricular function (LVEF\<50%)
• • Significant valvular pathology
• • Contraindication for treatment with sublingual nitrates as background medication only, at the discretion of the treating cardiologist.
• • Contraindications for treatment with vericiguat: resting systolic blood pressure\<100mmHg, severe renal impairment (estimated glomerular filtration rate \<15ml/min), severe hepatic impairment.
• • Known hypersensitivity to the active substance or to any of the excipients (Microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate).
• • Concomitant use of other soluble guanylate cyclase (sGC) stimulators, such as riociguat.
• • Concomitant use PDE5 inhibitors, such as sildenafil.
• • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
• • Patients who are pregnant or nursing and those who plan pregnancy in the period up to 1 month after the study;
• • Patients with a limited life expectancy less than one year;
• • Patients unable to provide written informed consent, or are otherwise not suitable for inclusion according to the investigator