Breathing Disorders in Patients With Congestive Heart Failure

Completed

• Conditions: Congestive Heart Failure
• Interventions: Other: Polysomnography

• Registration Number: NCT01047787
• Lead Sponsor: University of Sao Paulo

Brief Summary

The investigators prospectively evaluated 89 consecutive outpatients (29 female) with stable congestive heart failure. The presence of sleep disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) while awake were investigated by overnight polysomnography. Males and females were similar in age, body mass index, and LVEF. Prevalence of SDB was higher in males than females. During follow up of 25±10 months, 27% of the population died. Nonsurvivors had lower LVEF (p=0.01), worse NYHA class (p=0.03) a higher proportion of CSR-awake (p\<0.001) than survivors.

Detailed Description

Bakground: There is little information in sleep disordered breathing (SDB) in women with congestive heart failure (CHF). We studied consecutive CHF patients in order to compare SDB characteristics according to gender, and to determine overall mortality impact of SDB and Cheyne-Stokes respiration (CSR) while awake.

Methods: Eighty nine consecutive outpatients (29 female) with stable CHF (LVEF\<45%) were prospectively evaluated. The presence of SDB, as characterized by obstructive sleep apnea (OSA) and CSR during sleep, as well as CSR while awake before sleep onset, were investigated by overnight polysomnography.

Study Timeline

• Study Start: 2001-11
• Study Completion: 2004-03
• Status Verified: 2007-05
• Study First Submitted: 2007-05-15
• Study First Submitted QC: 2010-01-12
• Last Update Submitted: 2010-01-12
• Study First Posted: 2010-01-13
• Last Update Posted: 2010-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• Patients with resting left ventricular ejection fraction (LVEF) of less than 45% as determined by echocardiography;
• Stable clinical condition as defined by no changes in drug therapy for at least one month before evaluation.

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Exclusion Criteria

• Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHF Patients	Polysomnography	Congestive Heart Failure Patients