跳至主要内容
临床试验/NCT03804827
NCT03804827已完成不适用

Impact of Sleep Disordered Breathing on Cardiac Injury in Acutely Decompensated Congestive Heart Failure

University of California, San Diego2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年1月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Overnight Troponin Change Admission

研究概览

简要总结

The goal of this study is to determine if sleep disordered breathing results in a measurable degree of overnight myocardial stress/injury in patients with acutely decompensated congestive heart failure. A secondary goal is to determine of a period of medical management attenuates this sleep disordered breathing-induced cardiac injury in this patient population.

详细描述

Consecutive patients admitted to the hospital with acutely decompensated heart failure will be identified for potential enrollment in this study. Enrolled patients will first be asked to complete questionnaires to assess their symptoms and risk of having sleep apnea.

Relevant information will be obtained from the electronic medical record (age, gender, body mass index, co-morbidities, medications, prior echocardiography results). Subjects will then undergo a "type III" portable monitoring sleep study on the first or second night of their hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin saturation, and heart rate. Blood samples will be collected on the evening before (08:00 PM +/- 2 hours), and the morning after (06:00 AM +/-2 hours) sleep apnea testing. If not otherwise obtained clinically, echocardiography will be obtained within 48 hours of admission. After a period of medical management for acutely decompensated heart failure, subjects will then have a second portable sleep apnea study (with associated pre and post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or 6). Later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay etc. will be collected from the electronic medical record. Blood samples will be processed, stored, and subsequently analyzed for high-sensitivity cardiac troponin T and I.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients age 18-80 years admitted to University of California San Diego La Jolla campus (Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital) with acute decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or inpatient general medical services.

排除标准

  • Known diagnosis of sleep disordered breathing and on treatment while hospitalized.
  • Suspected acute coronary syndrome as determined by the primary clinical team.
  • Intensive care unit level care.
  • Requiring advanced heart failure therapy such as inotrope infusion, mechanical circulatory support etc.
  • Intolerance of study procedures.
  • Clinical attending physician refusal

结局指标

主要结局

Overnight Troponin Change Admission

时间窗: 10 hours

Overnight change in serum troponin concentration PRE vs POST sleep

Overnight Troponin Change Discharge

时间窗: 10 hours

Overnight change in serum troponin concentration PRE vs POST sleep

次要结局

未报告次要终点

研究者

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

Robert L. Owens

Assistant Professor

University of California, San Diego

研究点 (2)

Loading locations...

相似试验

Sleep Disordered Breathing in Acute Congestive Heart... | 临床试验