Efficacy of Diltiazem to improve coronary microvascular dysfunction: A randomized clinical trial

Efficacy of Diltiazem to improve coronary microvascular dysfunction: A randomized clinical trial - EDIT-CMD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49283

Enrollment

107

Registered

2019-07-24

Start date

2019-10-25

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Microvascular Dysfunction

Interventions

After establishing an abnormal coronary vascular function, 6 weeks treatment with either diltiazem 120-360 mg or placebo will be initiated in a double-blind fashion. Every two weeks dose titration w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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: a. Coronary angiography: patients with non-obstructive ( 0.80 or iFR > 0.89 on angiogram. b. Coronary computed tomography angiography (CCTA) with finding of non-obstructive coronary arteries 4. Baseline coronary reactivity testing with at least one of the following: a. CFR = 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

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 = 2 types of pulmonary medications for asthma and/or severe COPD with FEV1

Design outcomes

Primary

Measure	Time frame
The proportion of patients having a successful treatment with diltiazem, defined as normalization of at least one abnormal parameter A normal IMR is specified as IMR 2 and a normal acetylcholine test is specified as one without ECG abnormalities and without signs of spasm at the same acetylcholine dose used at baseline.	—

Secondary

Measure	Time frame
Change in the different parameters of the CRT (change in IMR, CFR, acetylcholine test parameters and absolute coronary blood flow).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)