Status:
ACTIVE_NOT_RECRUITING
Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: a Randomized Clinical Trial
Lead Sponsor:
Radboud University Medical Center
Conditions:
Microvascular Angina
Coronary Vasospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Rationale: Up to 40% of patients undergoing a coronary angiogram for symptoms/signs of ischemia do not have obstructive coronary artery disease (CAD). In about half of them the mechanism underlying ca...
Detailed Description
Primary Objective: To assess the effect of diltiazem on coronary microvascular function in patients with chronic angina and evidence of coronary microvascular dysfunction. Secondary Objectives: To ...
Eligibility Criteria
Inclusion
- Patients with chronic angina, defined as symptoms of angina at least 2 times a week despite medical therapy for the last 3 months.
- 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
- Baseline coronary function testing with at least one of the following:
- CFR ≤ 2.0
- IMR ≥ 25
- Abnormal acetylcholine test defined as the presence of (recognizable) angina, ischemic ECG abnormalities with or without epicardial spasm.
- Signed written informed consent \* Note: in cases of clinically suspected progression of atherosclerosis as per the Investigator, more contemporary (i.e., 6 months) evidence should be provided.
Exclusion
- Other cause of angina deemed highly likely by the treating physician.
- 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.
- Left ventricular ejection fraction \< 50%.
- Recent PCI within the past 3 months.
- Patients with history of coronary artery bypass grafting (CABG).
- Surgically uncorrected significant congenital or valvular heart disease, cardiomyopathy or myocarditis.
- Significant renal impairment (eGFR \< 30).
- Significant hepatic impairment (history or cirrhosis or abnormal serum ALT or AST 3-fold greater than the upper limit of normal).
- Pregnant women or women of child bearing potential who are planning to become pregnant within the next 3 months.
- Prior non-cardiac illness with an estimated life expectancy \< 1 year.
- Contra-indication to coronary function testing:
- Contraindication or known hypersensitivity to adenosine.
- Contraindication or known hypersensitivity to acetylcholine.
- Ongoing dipyridamole treatment.
- 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.
- Symptomatic hypotension or systolic BP \< 100 mmHg at screening visit on 2 consecutive measurements.
- 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.
- Participation in another clinical study with an IMP within one month prior to enrolment.
- 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.
- Unable to give informed consent (i.e. due to language barrier).
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04777045
Start Date
October 25 2019
End Date
December 1 2026
Last Update
March 30 2023
Active Locations (3)
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1
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
2
Catharina Hospital
Eindhoven, Netherlands
3
Maasstad Hospital
Rotterdam, Netherlands