NCT03936751终止4 期
Impact of Obstructive Sleep Apnea Treatment on Cardiovascular Events in Patients With Acute Cardiogenic Pulmonary Edema: a Multicenter Randomized Controlled Study (CPAP-CARE STUDY).
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Rate of ACPE recurrence
研究概览
简要总结
Despite the advances in the treatment of acute cardiogenic pulmonary edema (ACPE), the readmissions rates and cardiovascular events remain very high. In this context, it is possible that other potential risk factors may influence the poor prognosis of the ACPE. One of these potential candidates is Obstructive Sleep Apnea(OSA). This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with ACPE. The primary outcome will be to evaluate the impact of CPAP on the recurrence of ACPE in the 1-year follow-up.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive acute Cardiogenic Pulmonary Edema
- •Moderate to Severe OSA
排除标准
- •Professional drivers
- •Pregnancy
- •Non-Cardiogenic Pulmonary edema
- •Terminal cancer
结局指标
主要结局
Rate of ACPE recurrence
时间窗: 1-year
To evaluate the effects of CPAP on the recurrence of ACPE as compared to placebo
次要结局
- Rate of cardiovascular mortality(1-year)
- Rate of all-cause mortality(1-year)
- Number of new hospital admissions(1-year)
- Blood pressure effects ( (mmHg)(1-year)
- Levels of BNP levels (pg/ml)(1-year)
- Cardiac function (left ventricular ejection fraction - %)(1-year)
研究者
Luciano F Drager, MD, PhD
Associate Professor of Medicine
University of Sao Paulo
研究点 (7)
Loading locations...
相似试验
已完成
4 期
A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized TrialObstructive Sleep ApneaNCT01895348Yonsei University60
已完成
4 期
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic SyndromeSleep ApneaMetabolic SyndromeNCT02295202University of Sao Paulo100
Unknown
不适用
Evaluation of Sleep Apnea and Cardiac Rhythm Abnormalities After Surgery Under General AnesthesiaObstructive Sleep ApneaArrhythmiaNCT02833662University Hospital, Grenoble120
已完成
不适用
Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss SurgeryObstructive Sleep ApneaObesityNCT01697878Massachusetts General Hospital45
已完成
不适用
Stroke and CPAP Outcome Study 2Sleep Apnea, ObstructivePatient AdherenceStrokeNCT02809430University of Washington90