Breathing Disorders in Patients With Congestive Heart Failure

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01047787
First received: May 15, 2007
Last updated: January 12, 2010
Last verified: May 2007
  Purpose

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 Intervention
Congestive Heart Failure
Other: Polysomnography

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Breathing Disorders in Patients With Congestive Heart Failure: Gender and Mortality Impact

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Enrollment: 89
Study Start Date: November 2001
Study Completion Date: March 2004
Groups/Cohorts Assigned Interventions
CHF Patients
Congestive Heart Failure Patients
Other: Polysomnography
examination for sleep disorders

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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)

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01047787

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

No publications provided

Responsible Party: University of Sao Paulo, Rogerio Santos da Silva
ClinicalTrials.gov Identifier: NCT01047787     History of Changes
Other Study ID Numbers: 823/01
Study First Received: May 15, 2007
Last Updated: January 12, 2010
Health Authority: Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014