Sleep Disordered Breathing in Acute Congestive Heart Failure

Impact of Sleep Disordered Breathing on Cardiac Injury in Acutely Decompensated 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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Heart Failure; With Decompensation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093-0990
      • Altman Clinical and Translational Research Institute
    • San Diego, California, United States, 92121
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients admitted to University of California San Diego Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital with acutely decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or hospitalist (general medical) service.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Heart Failure With Sleep Disordered Breathing; AHI3% >/= 5 events per hour of sleep.
Heart Failure without Sleep Disordered Breathing; AHI3% < 5 events per hour of sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overnight Troponin Change Admission	Overnight change in serum troponin concentration PRE vs POST sleep	10 hours
Overnight Troponin Change Discharge	Overnight change in serum troponin concentration PRE vs POST sleep	10 hours

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): August 3, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Heart Failure; OSA; Sleep; CHF; Troponin; CSA
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Heart Failure; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 181121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No