Evaluation of Efficacy and Safety of Metoprolol XR in Patients Having Heart Failure With Normal Ejection Fraction: A Randomised, Double Blind,Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Proportion of patients showing improvement of ≥ 1 in NYHA class
研究概览
简要总结
In contrast to the treatment of HF with reduced EF, information to guide the pharmacological therapy of patients with HFNEF are lacking and there is no evidence based treatment for patients with HFNEF. Thus, present treatment strategies for HFNEF are largely based on assumptions regarding its pathophysiological mechanisms and on extrapolations from proven strategies used in systolic HF. Till now, no study enlightens the efficacy and safety of beta blockers in HFNEF in a randomised controlled manner although the role of beta blockers in HF with impaired systolic function has been sufficiently time tested leading to their therapeutic approval in that condition. Keeping in view the small reported benefit of beta blockers in HFNEF as mentioned above, there is a need to provide a conclusive proof of their role in this condition as well. Hence, investigators planned to test the efficacy and safety of metoprolol CR in patients with HFNEF in a randomised double blind placebo controlled trial.
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
- Double (Participant, 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
- •Age 18 years and above of either sex
- •Presence of New York Heart Association functional class II-IV of at least 4 weeks' duration
- •LVEF ≥ 50% in a nondilated LV (LV end-diastolic volume < 97 ml/m2 measured by echocardiography)
- •Echocardiographic evidence of LV diastolic dysfunction
- •Willing to give written informed consent
排除标准
- •Clinically unstable as defined by any change in diuretic dose in the month prior to enrolment.
- •Significant valvular heart disease, pericardial disease, hypertrophic or restrictive cardiomyopathy
- •Unstable angina or MI within the past 4 weeks.
- •Alternative probable cause of the patient's symptoms (e.g.significant pulmonary disease);
- •Any previous left ventricular ejection fraction below 40%
- •Other systemic disease limiting life expectancy to less than 3 years
- •Any contraindication to metoprolol use (heart rate less than 45 beats per minute, heart block greater than first-degree i.e. PR interval ≥ 0.24 second, systolic blood pressure <100 mm Hg, asthma)
- •Conditions associated with alteration in serum levels of procollagen type I e.g. alcoholic liver disease, metabolic bone disease, hyperthyroidism
- •Current participation (including prior 30 days) in any other therapeutic trial
- •Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol
研究组 & 干预措施
placebo capsule
干预措施: Metoprolol XR (Drug)
metoprolol XR capsule
干预措施: Metoprolol XR (Drug)
结局指标
主要结局
Proportion of patients showing improvement of ≥ 1 in NYHA class
时间窗: 12 weeks
次要结局
- proportion of patients exhibiting any alteration in NYHA heart failure class from baseline(12 weeks)
研究者
SHotra
professor
Post Graduate Institute of Medical Education and Research, Chandigarh