Effects of Ivabradine on Residual Myocardial Ischemia After PCI Evaluated by Stress Echocardiography
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)
研究概览
简要总结
This is a randomized pharmacological study evaluating the effects of ivabradine in patients with residual angina after PCI. The role of ivabradine in patients with angina, without systolic dysfunction, is not yet clear. The investigators performed in all patients an echostress to evaluate the effects of therapy with ivabradine after 30 days in terms of exercise tolerance and diastolic function.
详细描述
BACKGROUND. Residual angina after PCI is a frequently-occurring disease. Ivabradine improves symptoms but its role in patients without left-ventricular systolic dysfunction is still unclear. The aim was to quantify the effects of ivabradine in terms of MVO2 indicators and diastolic function.
METHODS. 28 consecutive patients with residual angina after PCI were randomized to ivabradine 5 mg twice/day(IG) or standard therapy(CG). All patients performed a stress echocardiography at the enrollment and after 30 days. Myocardial oxygen consumption was estimated from: double product(DP); triple product(TP) integrating DP with ejection-time(ET). Diastolic function was evaluated determining E and A waves, E' measurements and E/E' ratio both at rest and at the peak of exercise.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coronary artery disease with chronic stable angina for more than three months (Canadian Cardiovascular Society-CCS-class I-III);
- •percutaneous revascularization with stent implantation at least one;
- •signs/symptoms of residual ischemia; sinus rhythm; HR ≥ 70 bpm at rest;
- •ability to perform an echocardiogram stress test with the tilting bicycle stress test (BST);
- •good acoustic window;
- •age ≥ 18 years.
排除标准
- •drugs intolerance or hypersensitivity
- •EF ≤ 40 %
- •NYHA class III to IV;
- •atrial fibrillation or flutter
- •presence of a pacemaker or implantable defibrillator
- •II or III degree AV block
- •HR ≤ 70 bpm at rest or sick sinus syndrome
- •any condition that could interfere with the ability to exercise stress test like Wolff- Parkinson-White syndrome, left bundle branch block, left ventricular hypertrophy;
- •rate-corrected QT interval (QTc) greater than 500 ms or the use of drugs that prolong the QTc interval
- •symptomatic hypotension or uncontrolled hypertension (systolic blood pressure at rest ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg)
- •severe liver disease and severe renal impairment (creatinine clearance ≤ 30 ml/min)
- •electrolyte disorders
- •uncontrolled thyroid disease
- •pregnancy.
研究组 & 干预措施
Ivabradine Group
drug therapy according to the guidelines + Ivabradine 5 mg twice a day
干预措施: Ivabradine (Drug)
结局指标
主要结局
Double product (DP) calculated as a product between HR and systolic blood pressure. (unit of measure: beats per minute x mmHg)
时间窗: 30 days
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
chronotropic reserve (unit of measure: beats per minute)
时间窗: 30 days
difference between resting heart rate and maximum heart rate at peak exercise
Triple product (TP), calculated as a product between HR, systolic blood pressure and ejection time. (unit of measure: beats per minute x mmHg x msec)
时间窗: 30 days
These, indirectly, reflect the true myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
muscular work (unit of measure: watt)
时间窗: 30 days
These, indirectly, reflect the myocardial oxygen consumption (MVO2) and the improvement of mechanical load that the ventricle can withstand at different levels of exercise.
次要结局
- diastolic function: TDI derived E' measurements (unit of measure: cm/sec)(30 days)
- diastolic function: PW Doppler E wave (unit of measure: cm/sec)(30 days)
- diastolic function: PW Doppler A wave (unit of measure: cm/sec)(30 days)
- E/E' ratio(30 days)
研究者
Massimo Mancone
(MD, PhD) Principal Investigator
Azienda Policlinico Umberto I