CTIS2024-512030-15-00进行中（未招募）1 期
Efficacy of Diltiazem to improve coronary microvascular dysfunction: a randomized clinical trial
Stichting Radboud universitair medisch centrum0 个研究点目标入组 126 人开始时间: 2024年3月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 126
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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
排除标准
- •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).
研究者
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