Breathing Disorders in Patients With Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01047787
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : January 13, 2010
Information provided by:
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.

Condition or disease Intervention/treatment
Congestive Heart Failure Other: Polysomnography

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 Type : Observational
Actual Enrollment : 89 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Breathing Disorders in Patients With Congestive Heart Failure: Gender and Mortality Impact
Study Start Date : November 2001
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Group/Cohort Intervention/treatment
CHF Patients
Congestive Heart Failure Patients
Other: Polysomnography
examination for sleep disorders

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with CHF recruited from the outpatient Heart Failure Unit of the Heart Institute (Instituto do Coraçao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01047787

Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Rogerio S Silva, PhD University of Sao Paulo

Responsible Party: University of Sao Paulo, Rogerio Santos da Silva Identifier: NCT01047787     History of Changes
Other Study ID Numbers: 823/01
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: May 2007

Keywords provided by University of Sao Paulo:
Sleep apnea
Cheyne-Stokes Respiration
Congestive Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases