EDIT-CMD

Phase 1

• Conditions: Angina; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2024-512030-15-00
• Lead Sponsor: Stichting Radboud universitair medisch centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1.Patients above the age of 18. 2.Patients with chronic angina, defined as symptoms of angina at least 2 times a week despite medical therapy for the last 3 months. 3.No signs of obstructive coronary artery disease (CAD), documented within 5 years* before inclusion by one of the following modalities: •Patients with non-obstructive (< 50% stenosis) coronary arteries, or patients with one or more intermediate stenoses (between 50 and 70%) with documented FFR > 0.80 or iFR > 0.89 on angiogram. •Coronary computed tomography angiography (CCTA) with finding of non-obstructive coronary arteries 4.Baseline coronary function testing with at least one of the following: a.CFR = 2.0 b.IMR = 25 c.Abnormal acetylcholine test defined as the presence of (recognizable) angina, ischemic ECG abnormalities with or without epicardial spasm. 5.Signed written informed consent

Exclusion Criteria

1.Other cause of angina deemed highly likely by the treating physician. 2.Active use of calcium channel blockers or any use of calcium channel blockers in the previous two weeks or known intolerance for non-dihydropyridine calcium channel blockers. 3.Left ventricular ejection fraction < 50%. 4.Recent PCI within the past 3 months. 5.Patients with history of coronary artery bypass grafting (CABG). 6.Surgically uncorrected significant congenital or valvular heart disease, cardiomyopathy or myocarditis. 7.Significant renal impairment (eGFR < 30). 8.Significant hepatic impairment (history or cirrhosis or abnormal serum ALT or AST 3-fold greater than the upper limit of normal). 9.Pregnant women or women of child bearing potential who are planning to become pregnant within the next 3 months. 10.Prior non-cardiac illness with an estimated life expectancy < 1 year. 11.Contra-indication to coronary function testing: a.Contraindication or known hypersensitivity to adenosine. b.Contraindication or known hypersensitivity to acetylcholine. c.Ongoing dipyridamole treatment. 12.Contra-indication for treatment with CCB: second or third degree AV block, sinus node dysfunction, bradycardia (heart rate < 50 beats/minute) and/or potentially dangerous interaction due to the use of another CYP3A4 substrate in the opinion of the investigator. 13.Symptomatic hypotension or systolic BP < 100 mmHg at screening visit on 2 consecutive measurements. 14.History of hospitalization for asthma and/or current use of = 2 types of pulmonary medications for asthma and/or severe COPD with FEV1 < 50% of predicted. 15.Participation in another clinical study with an IMP within one month prior to enrolment. 16.Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study. 17.Unable to give informed consent (i.e. due to language barrier).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified