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临床试验/NCT00727454
NCT00727454终止4 期

Effects of Continuous Positive Airway Pressure on Heart Remodeling in Patients With Obstructive Sleep Apnea: A Randomized Study With Cardiovascular Magnetic Resonance Imaging

University of Sao Paulo4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年7月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
24
试验地点
4
主要终点
Right ventricle parameters: size and function.

研究概览

简要总结

Obstructive sleep apnea (OSA) is independently associated with important heart remodeling that further contributes to overt heart failure. Recent evidences using echocardiogram suggested that continuous positive airway pressure (CPAP) has beneficial effects mainly on left ventricle parameters. However, the evidences regarding the right ventricle are scanty. In addition, no previous studies evaluated morphological and functional characteristics in OSA by magnetic resonance imaging (MRI) as well as the impact of CPAP.

详细描述

The patients will be recruited from the Sleep Laboratory, Heart Institute (InCor), University of São Paulo Medical School. Male adults with a sleep study within 1 month showing severe OSA (>30 events of apnea and hypopnea per hour of sleep) and naive to treatment will be considered for the study. Age and body mass index matched controls will be recruited from the hospital staff and their relatives. All volunteers will be previously screening for the risk of OSA with Berlin Questionnaire. To minimize confounding risk factors, we will exclude subjects older than 60 years and those with a body mass index (BMI) >40 kg/m2, diabetes mellitus, hypertension, cerebrovascular disease, valvular heart disease, renal failure, current or past smoking history, and chronic use of any medication. Hypertension will be excluded after 3 or more normal blood pressure values (<140/90mm Hg) obtained on separate occasions with a conventional mercury sphygmomanometer.

Sleep Study. All participants will perform a standard overnight polysomnography. Apnea will be defined as complete cessation of airflow for at least 10 seconds, associated with oxygen desaturation of 3%. Hypopnea will be defined as a significant reduction (>50%) in respiratory signals for at least 10 seconds associated with oxygen desaturation of 3%. The apnea-hypopnea index will be calculated as the total number of respiratory events (apneas plus hypopneas) per hour of sleep. Normal values will be considered when the apnea-hypopnea index will be <5events/hour.

The participants will be randomly assigned to no treatment (control) or treatment with CPAP for 3 months, according to a computer-generated list of random numbers. At baseline and after 3 months, the participants will be submitted to cardiac MRI.

Magnetic resonance imaging methods. Participants will perform MRI examination on 1.5 - T GE CV/i system. Short and long-axis of the heart will be obtained during breath-hold and triggered on electrocardiogram pulse sequences. The first sequence will be a gradient-echo (steady-sate free procession) to assess left ventricular (LV) and right ventricular (RV) morphology and function. The second sequence will be an inversion-recovery prepared gradient-echo to obtain MDE (10 to 20 minutes after intravenous bolus of 0.2 mmol/Kg of gadolinium-based contrast). We will use the following parameters: repetition time 3.9/7.1ms, echo time 1.7/3.1 ms, flip angle 45º/20º, cardiac phases 20/1, views per segment 8/16 to 32, matrix 256 x 128/256 x 192, slice thickness 8/8mm, gap between slices 2/2mm and field of view 32 to 38/32 to 38 cm, inversion time none/150 to 250 ms, receiver bandwidth 125/31,25 kHz, number of excitations 1/2.

Blood Samples. Venous blood will be collected from all participants between 8 and 10 AM for the measurement of glucose, total cholesterol, low-density lipoprotein, high-density lipoprotein, and red blood cell count.

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
Single (Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients free of comorbidities with severe Obstructive Sleep Apnea by polysomnography.
  • Healthy volunteers (no obstructive sleep apnea and no comorbidities) matched for age, sex and body mass index.

排除标准

  • Subjects older than 60 years
  • Body mass index (BMI) >40 kg/m2
  • Diabetes mellitus
  • Hypertension
  • Cerebrovascular disease
  • Valvular heart disease
  • Renal failure
  • Current or past smoking history
  • Chronic use of any medication

结局指标

主要结局

Right ventricle parameters: size and function.

时间窗: Baseline and after 3 months.

次要结局

  • Left Ventricle parameters: size and function(Baseline and after 3 months.)

研究者

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

Luciano F Drager

Luciano F. Drager

University of Sao Paulo

研究点 (4)

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