BridgeMD
EDIT-CMD
EU CTIS ID: 2024-512030-15-00
What this study is testing
Our primary objective is to assess the effect of diltiazem on coronary microvascular function as assessed by CFT in symptomatic patients with CMD. Our secondary objective is to assess the effect of diltiazem on the individual coronary function parameters.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.