Skip to main content
OpenTrials
Completed

NCT Number: NCT03804827

Sleep Disordered Breathing in Acute Congestive Heart Failure

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Altman Clinical and Translational Research Institute, San Diego, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Overnight Troponin Change Admission

    Time frame: 10 hours

    Overnight change in serum troponin concentration PRE vs POST sleep

  2. Overnight Troponin Change Discharge

    Time frame: 10 hours

    Overnight change in serum troponin concentration PRE vs POST sleep

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2019
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.