A Prospective, Randomized, Double-blind Placebo-controlled Study to Determine the Efficacy of 8 mg/Day Oral Perindopril to Prevent the Recurrence of Atrial Fibrillation in Patients With Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint will be time to first sustained recurrence of AF.
研究概览
简要总结
The purpose of this 7- to 13-month study is to determine the efficacy of 8 mg/day oral perindopril to prevent the recurrence of atrial fibrillation (AF) in patients with essential hypertension.
详细描述
Hypertension affects approximately 50 million individuals in the United States and approximately 1 billion individuals worldwide. As the population ages, the prevalence of hypertension is expected to increase even further unless broad and effective preventive measures are implemented. Recent data from the Framingham Heart Study suggest that individuals who are normotensive at 55 years of age have a 90% lifetime risk for developing hypertension. The relationship between blood pressure (BP) and risk of cardiovascular disease (CVD) events is continuous, consistent, and independent of other risk factors. The higher the BP, the greater is the chance of myocardial infarction, heart failure (HF), stroke, and kidney disease.
Atrial fibrillation (AF) is also a major health problem and has been described as one of two emerging cardiovascular epidemics at the turn of the century. It is the most frequent cardiac arrhythmia, affecting 5% of individuals aged > 65 years, and it is associated with an increased risk of stroke and a doubling of all-cause mortality. The loss of effective atrial contraction may result in impaired cardiac performance, reduced exercise tolerance and congestive heart failure. In addition, patients with atrial fibrillation often have disabling palpitations.
Perindopril (Coversyl) is an angiotensin-converting enzyme (ACE) inhibitor with demonstrated efficacy in controlling hypertension. There are several lines of evidence suggesting that ACE inhibition may reduce the incidence of new-onset AF as well as AF recurrences.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be age 18 years or older.
- •Patients may be either male or female without childbearing potential (or with adequate contraception).
- •Patients must have a current diagnosis of essential hypertension with systolic blood pressure (SBP) ≤ 160 mmHg and diastolic blood pressure (DBP) ≤ 100 mmHg at the time of inclusion visit AND
- •Patients must have had at least one episode of symptomatic paroxysmal or persistent atrial fibrillation within the preceding six months:
- •With an indication for cardioversion in the case of persistent AF
- •With electrocardiogram (ECG) documentation of AF
- •With duration of an AF episode of at least 10 minutes
排除标准
- •Unlikely to co-operate in the study
- •Pregnancy, breastfeeding, or possibility of becoming pregnant during the study (patients must have adequate contraception as determined by the investigator).
- •Alcoholism or drug abuse
- •Participation in another study at the same time or within 30 days of randomisation.
- •Left ventricular systolic dysfunction with an ejection fraction of 45% or less
- •Myocardial infarction within the past month prior to the selection visit
- •Cardiac or thoracic surgery within the past 3 months or likely to be performed during the trial
- •Chronic AF (continuously present for > 6 months)
- •AF secondary to an acute reversible condition (e.g. post-operative atrial fibrillation, hyperthyroidism)
- •Currently requiring class I or class III anti-arrhythmic drug therapy (for atrial fibrillation or any other arrhythmia)
- •Any medical condition that makes the patient an unsuitable candidate in the investigator's opinion
- •Any medical condition requiring ACE inhibitor or angiotensin-receptor blocker therapy (e.g. diabetes, known proteinuria of more than 300 mg per day)
- •Renal insufficiency with serum creatinine of 180 μmol/L or greater
- •Known bilateral renal artery stenosis
- •Serum potassium of 5.0 mmol/L or greater on recent laboratory exam
- •Positive pregnancy test (beta human chorionic gonadotropin [HCG] performed in women of childbearing potential)
- •Known intolerance to ACE inhibitor
- •Impossibility to discontinue certain treatments at selection visit
- •Known contraindication(s) to perindopril
- •Severe known liver disease including cirrhosis, biliary obstruction or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation more than 3 times the upper limit of normal
- •Use of ACE inhibitor or angiotensin-receptor blocker in the 3 months before the inclusion visit
- •Severely uncontrolled hypertension with SBP > 160 mmHg or DBP > 100 mmHg at the inclusion visit.
研究组 & 干预措施
Placebo (for perindopril)
Sugar pill manufactued to mimic perindopril
干预措施: Perindopril (Drug)
Perindopril
Perindopril (coversyl) 4 mg tablets
干预措施: Perindopril (Drug)
结局指标
主要结局
The primary efficacy endpoint will be time to first sustained recurrence of AF.
时间窗: 12 months follow-up
1 month treatment adjustment 3 months of endpoint follow-up - M4 6 months of endpoint follow-up - M7 12 months of endpoint follow-up - M13
次要结局
- Secondary efficacy endpoints will be the proportion of patients without AF throughout the 6 months of follow-up, number of documented relapses of AF, and health care resource utilization (including hospitalisations for AF and cardioversions).(6 months follow-up)