NCT01047787

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2001

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
Last Updated

January 13, 2010

Status Verified

May 1, 2007

First QC Date

May 15, 2007

Last Update Submit

January 12, 2010

Conditions

Congestive Heart Failure

Keywords

Sleep apneaCheyne-Stokes RespirationCongestive Heart Failure

Study Arms (1)

CHF Patients

Congestive Heart Failure Patients

Other: Polysomnography

Interventions

PolysomnographyOTHER

examination for sleep disorders

CHF Patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart FailureSleep Apnea SyndromesCheyne-Stokes Respiration

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rogerio S Silva, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2007

First Posted

January 13, 2010

Study Start

November 1, 2001

Study Completion

March 1, 2004

Last Updated

January 13, 2010

Record last verified: 2007-05