Breathing Disorders in Patients With Congestive Heart Failure

NCT ID: NCT01047787

Last Updated: 2010-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-11-30

Study Completion Date

2004-03-31

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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CHF Patients

Congestive Heart Failure Patients

Polysomnography

Intervention Type OTHER

examination for sleep disorders

Interventions

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Polysomnography

examination for sleep disorders

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rogerio Santos da Silva

Principal Investigators

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Rogerio S Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Other Identifiers

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823/01

Identifier Type: -

Identifier Source: org_study_id

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