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临床试验/NCT00869869
NCT00869869撤回2 期

Restoration of Sleep in Heart Failure Patients

Brigham and Women's Hospital1 个研究点 分布在 1 个国家开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Change in sleep quantity assessed by actigraphy

研究概览

简要总结

The purpose of this study is to determine whether melatonin can improve sleep, quality of life and markers of heart failure in patients with heart failure.

详细描述

Heart failure affects nearly 5 million individuals in the United States and constitutes a prime risk factor for morbidity and mortality. Beta-blockers are a class of drugs that form a critical part of the best treatment of heart failure, and thereby decrease the risk for these serious problems. Beta-blockers also lower the levels of melatonin, a hormone that has a sleep-promoting effect. Most patients with heart failure take beta-blockers and have poor sleep, which may be related to the beta-blockers' effect on melatonin levels. This study will evaluate the effectiveness of treatment with melatonin supplements in improving sleep in individuals with heart failure who are taking beta-blockers. In addition, the study will examine whether the melatonin supplements aid in improving quality of life and measures of heart failure.

Participants in this double-blind study will be randomly assigned to receive either melatonin supplements or placebo for the duration of the study.

The study will mainly take place at home, where participants will complete sleep diaries, measure blood pressure and wear a wrist watch that measures movement for 5-6 weeks. During that time there will be three visits to the hospital where plasma and urine samples will be collected and questionnaires will be completed.

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
35 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with heart failure NYHA Class 2 or 3
  • Currently being treated with beta-blocker

排除标准

  • Diagnosed with obstructive sleep apnea
  • Using Fluvoxamine, Warfarin, Nifedipine, or Calcium Channel Blockers

研究组 & 干预措施

placebo

Placebo Comparator

placebo

干预措施: placebo (Drug)

melatonin

Experimental

melatonin

干预措施: melatonin (Drug)

结局指标

主要结局

Change in sleep quantity assessed by actigraphy

时间窗: measured during ambulatory phase

次要结局

  • Change in quality of life and heart failure biomarkers(measured during study visits)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank AJL Scheer, PhD

Associate Professor of Medicine

Brigham and Women's Hospital

研究点 (1)

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