Effect of Melatonin on Cardiovascular and Muscle Function in Patients With Heart Failure: a Double Blinded Prospective Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Composite clinical endpoint score
研究概览
简要总结
The main aim of this study is to investigate the effect of melatonin on clinical outcome, quality of life, and cardiovascular function of the patients with heart failure, as well as its effect on their skeletal muscle mass and function.
详细描述
People with heart failure (HF) suffer from various comorbidities and complications which their management is as important as treatment of HF per se. An important complication of the HF is progressive decrease in muscle mass and function known as muscle wasting or sarcopenia. Prevention, diagnosis, and treatment of muscle wasting is emphasized to improve prognosis and quality of life of the patients with HF. Melatonin is a natural hormone which is secreted from pineal gland and is involved in circadian rhythm control. Recent data delineates more important roles for melatonin in cellular metabolism and apoptosis, as well as acting as an antioxidant and anti-inflammatory agent in the body. Experimental studies show that melatonin can have a beneficial role in muscle wasting in several chronic conditions such as heart failure. Furthermore melatonin has been shown to have valuable effects on cardiovascular health, blood pressure, and endothelial function and it might benefit patients with heart failure. In this study the effect of melatonin on clinical outcome and quality of life of the patients with HF and their echocardiographic parameters, muscle mass, muscle function, inflammatory biomarkers, serum metabolic parameters, and serum oxidative stress markers will be studied.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic heart failure with ejection fraction < 40, either ischemic or dilated cardiomyopathy (DCM)
- •Symptoms and medications of HF have been stable for at least three months
- •NYHA class II-III
- •Willing to participate in the study and providing informed consent
排除标准
- •Chronic comorbidities: insulin dependent diabetes, renal failure (GFR < 30 mL/min per 1.73 m2), uncontrolled endocrine disease, end-stage liver disease, rheumatological disease, chronic obstructive pulmonary disease (class D according to GOLD classification), morbid obesity (BMI > 35)
- •Acute ischemic heart event or revascularization procedure in the last month
- •Regular supervised exercise or ingestion of muscle hypertrophy supplementations in the last three months
- •Vegetarian diet or sever restriction of protein in the diet in the last three months
- •Occurrence of melatonin related adverse effects
研究组 & 干预措施
Melatonin
Melatonin (10 mg tablets) by oral root, ingested at bedtime for 6 months
干预措施: Melatonin 10 mg (Drug)
Placebo
Placebo tablets in the same shape as melatonin tablets, ingested the same as the melatonin tablets.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Composite clinical endpoint score
时间窗: 6 months or earlier if patient was dropped out from the study
A score with the following components: all-cause mortality, hospitalization for heart failure during the study, and change in quality of life by Minnesota Living with Heart Failure Questionnaire (MLHFQ)
次要结局
- Adverse effects of melatonin(Throughout the study up to 6 months)
- Change in lean body mass (kg)(Baseline and 6 months)
- Change in grip strength (kg)(Baseline and 6 months)
- Change in exercise capacity(Baseline and 6 months)
- Change in left ventricular end-systolic volume (LVESV)(Baseline and 6 months)
- Change in endothelial dysfunction(Baseline and 6 months)
- Change in appendicular lean mass (kg)(Baseline and 6 months)
- Change in Left ventricular ejection fraction (LVEF)(Baseline and 6 months)
- Change in mean systolic and diastolic blood pressures(Baseline and 6 months)
研究者
Masoumeh Sadeghi
Head of Cardiac Rehabilitation Research Center
Isfahan University of Medical Sciences