Heart Rate Control: Betablockers or Ivabradine Therapy Before Cardiac Computed Tomography
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Dose and type of drugs with the swiftest heart rate reduction in patients undergoing cardiac computed tomography
研究概览
简要总结
The goal of this clinical trial is to describe which type and dose of commonly used heart rate reducing drugs (metoprolol, atenolol, or ivabradine) has the swiftest heart rate reduction from baseline in patients aged 30 to 80 years with a heart rate > 65 beats per minute undergoing cardiac computed tomography for the evaluation of coronary artery disease. The main question it aims to answer is
• Which type of heart reducing drug and dose has the swiftest heart rate reduction before cardiac computed tomography?
详细描述
This single-center, prospective, randomized, double-blind, clinical trial will include patients undergoing cardiac computed tomography. Two phases will be conducted: a pilot study (dose-finding phase) and a randomized trial (superiority phase). In the first dose-finding phase participants (N=150) will be randomized 1:1 in six arms (arms contain lower and higher doses of atenolol, metoprolol and ivabradine). Following an interim analysis, a superiority phase will be conducted using two parallel groups, non-diabetics (N=100) and diabetics (N=100), in a placebo-controlled head-to-head randomized 2:2:1 three-arms trial comparing the fastest betablocker and dose and the fastest dose of ivabradine from the dose-finding phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals who are to undergo Cardiac CT
- •Sinus rhythm with heart rate > 65 bpm on ECG
- •Competent patients who have given written informed consent
排除标准
- •Age > 80 years
- •Age < 30 years
- •Heart rate > 100 bpm
- •BMI > 35
- •Previous percutaneous coronary intervention (with or without stent)
- •Previous CABG
- •Known ischemic heart disease
- •Pacemaker
- •Acute coronary syndrome
- •Known allergy to beta-blockers
- •Known allergy to ivabradine
- •Known allergy to used radiographic contrast agents
- •Pregnant, including potentially pregnant, or breastfeeding (potentially pregnant patients will undergo pregnancy testing)
- •Heart failure with systolic left ventricular ejection fraction < 45%
- •Reduced kidney function with estimated glomerular filtration rate (eGFR) < 40 ml/min
- •Regular treatment with beta-blockers
- •Regular treatment with ivabradine
- •Regular treatment with non-dihydropyridine calcium antagonists (Verapamil and Diltiazem)
- •Regular treatment with Cordarone
- •Contraindications for beta-blockers or ivabradine:
- •Severe asthma
- •Severe COPD
- •Sick sinus syndrome
- •Sinoatrial block (1st degree AV block)
- •Advanced AV block (2nd or 3rd degree)
- •Hypotension (systolic blood pressure < 110 mmHg)
- •Severe heart failure
- •Severe restrictive cardiomyopathy
- •Severe aortic stenosis
- •Severe circulatory disturbances
- •Severe metabolic conditions
- •Untreated pheochromocytoma
- •Concurrent treatment with potent inhibitors of CYP3A4
- •Concurrent treatment with potent inhibitors of MAO inhibitors,
- •Concurrent treatment with potent inhibitors of CYP2D6 inhibitors
- •Concurrent treatment with potent inhibitors of intravenous calcium antagonists type I or III
研究组 & 干预措施
Placebo
Strategy 2
干预措施: Ivabradine 7.5/15 mg (Drug)
Metoprololtartrat 50 mg
Strategy 1
干预措施: atenolol (Drug)
Metoprololtartrat 50 mg
Strategy 1
干预措施: Ivabradine (Drug)
Metoprololtartrat 100 mg
Strategy 1
干预措施: atenolol (Drug)
Metoprololtartrat 100 mg
Strategy 1
干预措施: Ivabradine (Drug)
Atenolol 50 mg
Strategy 1
干预措施: Metoprolol tartrate (Drug)
Atenolol 50 mg
Strategy 1
干预措施: Ivabradine (Drug)
Atenolol 100 mg
Strategy 1
干预措施: Metoprolol tartrate (Drug)
Atenolol 100 mg
Strategy 1
干预措施: Ivabradine (Drug)
Ivabradine 15 mg
Strategy 1
干预措施: atenolol (Drug)
Ivabradine 15 mg
Strategy 1
干预措施: Metoprolol tartrate (Drug)
Ivabradine 7.5 mg
Strategy 1
干预措施: atenolol (Drug)
Ivabradine 7.5 mg
Strategy 1
干预措施: Metoprolol tartrate (Drug)
Fastest dose of betablocker (atenolol 50/100 mg or metoprololtartrat 50/100 mg)
Strategy 2
干预措施: Ivabradine 7.5/15 mg (Drug)
Fastest dose of Ivabradine (Ivabradine 7.5/15 mg)
Strategy 2
干预措施: Atenolol/Metoprolol tartrate (Drug)
Placebo
Strategy 2
干预措施: Atenolol/Metoprolol tartrate (Drug)
结局指标
主要结局
Dose and type of drugs with the swiftest heart rate reduction in patients undergoing cardiac computed tomography
时间窗: From adminstration of study drug to start af cardiac computed tomography, 2 hours
Time in minutes to heart rate (mean) lowered by 10% from baseline after administration of study drug
次要结局
- Proportion of patients with heart rate <60 beats per minute(From adminstration of study drug to start af cardiac computed tomography, 2 hours)
- Total heart rate reduction in beats per minute after 120 minutes(From adminstration of study drug to start af cardiac computed tomography, 2 hours)
- Number of patients in need of an intravenous betablocker(From adminstration of study drug to start af cardiac computed tomography, 2 hours)
- Efficacy of intravenous administration of betablocker(From adminstration of study drug to start af cardiac computed tomography, 2 hours)
- Evaluation of side effects, safety, and tolerability of metoprolol, atenolol, and ivabradine(From intervention af study drug to phone contact to patient 1 week after cardiac computed tomography)