Sleep Disordered Breathing in Acute Congestive Heart Failure

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804827
• Other study ID #: 181121
• Status: Completed
• Start date: January 14, 2019
• Est. completion date: August 3, 2021

Study information

• Verified date: August 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure; With Decompensation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	Altman Clinical and Translational Research Institute	San Diego	California
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overnight Troponin Change Admission	Overnight change in serum troponin concentration PRE vs POST sleep	10 hours
Primary	Overnight Troponin Change Discharge	Overnight change in serum troponin concentration PRE vs POST sleep	10 hours