Randomized, Prospective, Parallel Group, Placebo-Controlled, Multi-Center Study on the Use of Valsartan an Angiotensin II AT1-Receptor Blocker in the Prevention of Atrial Fibrillation Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,442
- 试验地点
- 107
- 主要终点
- To demonstrate that, in patients with history of recent AF treated with the best recommended therapies, the addition of valsartan (titrated up to 320 mg daily) is superior to placebo in reducing over the whole follow-up:
研究概览
简要总结
Study purpose The purpose of the study is to show that the addition of valsartan on top of established therapies can reduce the recurrence of atrial fibrillation in patients with a history of recent atrial fibrillation associated with cardiovascular diseases/comorbidities.
Primary objective To demonstrate that, in patients with history of recent atrial fibrillation treated with the best recommended therapies, the addition of valsartan 320 mg is superior to placebo in reducing atrial fibrillation recurrence.
Study design The GISSI-AF is a prospective, multicenter, randomized, double blind, placebo controlled study. Patients with a history of atrial fibrillation will be centrally randomized in a 1:1 ratio to receive either valsartan or placebo.
GISSI-AF will be a pragmatic trial, with broad selection criteria to mimic real clinical practice as much as possible. Since no special examinations or procedures are required for the trial, the economic impact on the National Health Service will be minimized and use of resources likely to be optimized. The enrollment period will last 12 months. The patients will be followed up for 12 months from study entry
All prescribed treatments for AF or for the underlying cardiovascular diseases, including ACE-inhibitors, amiodarone and betablockers, will be allowed:
- patients should be on a stable treatment for at least one month
- the current guideline for hypertension treatment should be applied
- patients should not be started on ARBs during the study
详细描述
The protocol is sponsored by an independent organization and partially supported by Novartis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients >=40 years of age
- •Sinus rhythm
- •At least two ECG documented episodes of symptomatic AF in the previous 6 months or After a successful cardioversion for AF performed between 14 days and 48 hours before randomization
- •At least one of the following underlying cardiovascular diseases/comorbidities:
- •heart failure/documented history of LV dysfunction (defined as an EF <40%)
- •history of hypertension >=6 months with/without LVH
- •Type II diabetes mellitus
- •documented history of stroke or peripheral vascular disease
- •documented history of coronary artery disease
- •lone atrial fibrillation with documented LA dilation (LA diameter >=45 mm for men and >=40 mm for women)
- •Written informed consent to participate in the study prior to any study procedures
排除标准
- •Need for a continuous treatment with ARBs for any clinical reasons
- •Contraindications or known hypersensitivity to ARBs
- •Persistent standing systolic blood pressure < 110 mmHg
- •Recent (<6 weeks) acute myocardial infarction or bypass surgery, or percutaneous coronary intervention
- •Clinically significant valvular etiologies
- •Thyroid dysfunction
- •Indication for pacemaker or ICD implant or for an ablative treatment, recent (<6 months) PM or ICD implant, previous ablative treatment
- •Planned cardiac surgery, expected to be performed within 3 months
- •Serum creatinine level above 2.5 mg/dL
- •Significant liver disease
- •Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception
- •Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol
- •Presence of any non-cardiac disease (e.g. cancer) that is likely to significantly shorten life expectancy
- •Treatment with any investigational agent within 1 month before randomization
- •Currently decompensated heart failure
研究组 & 干预措施
1
干预措施: Valsartan (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
To demonstrate that, in patients with history of recent AF treated with the best recommended therapies, the addition of valsartan (titrated up to 320 mg daily) is superior to placebo in reducing over the whole follow-up:
时间窗: Time to first AF recurrence
First recurrence of AF,
时间窗: time to first AF recurrence
Rate of patients with more than one AF episode,
时间窗: end of follow-up
次要结局
- Number of AF episodes(end of fw-up)
- Number of hospitalizations for CV reasons(end of fw-up)
- Number of all-cause hospitalizations(end of fw-up)
- Incidence of thromboembolic events(end of fw-up)
- Number of patients who die or with non-fatal thromboembolic events(end of fw-up)
- Number of patients in sinus rhythm at the time of each study visit(end of fw-up)
- Number of patients in sinus rhythm who did not have any prior AF recurrence during the study(end of fw-up)
- Duration and characteristics (ventricular rate) of the first recurrence of AF.(end of fw-up)