The Effect of Ubiquinol Treatment on Cardiac Function in Patients With Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography
研究概览
简要总结
There are no studies specifically examining the effects of coenzyme Q (CoQ) treatment on echocardiographic indices of diastolic function in elderly patients with heart failure with preserved ejection fraction (HFPEF). In previous studies the only echocardiographic parameters studied were ejection fraction (EF) and chamber size. The objective of the proposed current study is to examine the effect of 16 weeks of ubiquinol therapy on diastolic function assessed by echocardiography in patients over the age of 50 with a clinical diagnosis of HFPEF. Ubiquinol (Kaneka Pharma), the reduced form of CoQ will be utilized for this study as it has been shown to have superior bioavailability when compared to oxidized CoQ.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Typical signs and symptoms of congestive heart failure (CHF) (New York Association Class 2-4).
- •Normal ejection fraction on echocardiography (EF ≥50%).
- •Evidence of diastolic dysfunction on non-invasive imaging (E:e' > 15 or e:e' > 8 with other measures of diastolic dysfunction such as e/a < 0.5 with elevated deceleration time or left atrial volume index > 40 cc/m2 or presence of elevated left ventricular mass index or elevated pulmonary pressures).
- •Stable medical therapy for 4 weeks prior to randomization
排除标准
- •Chronic atrial fibrillation.
- •Acute coronary syndrome or coronary revascularization within 60 days.
- •Clinically significant valvular disease.
- •Known infiltrative cardiomyopathy (e.g. amyloidosis), hypertrophic cardiomyopathy or chronic pericardial disease.
- •Inability/refusal to provide informed consent
研究组 & 干预措施
Placebo
Placebo three times daily
干预措施: Placebo (Drug)
Active
Pills of 100 mg ubiquinol three times daily
干预措施: ubiquinol (Drug)
结局指标
主要结局
Change in diastolic function as assessed by mitral valve inflow and tissue Doppler velocities on echocardiography
时间窗: 4 months
NT-pro brain natriuretic peptide (NT-proBNP) serum levels (pg/ml)
时间窗: 4 months
次要结局
未报告次要终点
研究者
LEIBOWITZ DAVID
Associate professor of medicine Hadassah-Hebrew University Medical Center
Hadassah Medical Organization