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CompletedNCT01047787Updated Jan 13, 2010

Breathing Disorders in Patients With Congestive Heart Failure

An observational study in Congestive Heart Failure, sponsored by University of Sao Paulo. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-01-13.

Sponsored by University of Sao Paulo · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
89
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Congestive Heart Failure

Keywords

  • Sleep apnea
  • Cheyne-Stokes Respiration
  • Congestive Heart Failure
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 89 is below the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,030 studies on the registry; 92 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
89 participants (actual)

Groups and cohorts

  • CHF Patients

    Congestive Heart Failure Patients

    Other: Polysomnography

Interventions

  • OtherPolysomnography

    examination for sleep disorders

06

Study locations

No study locations are listed for this record.

07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2001 and a completion of Mar 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2007
First posted
Jan 13, 2010
Start
Nov 2001
CompletionActual
Mar 2004
Last update
Jan 13, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01047787
First posted
Jan 13, 2010
Start date
Nov 2001
Completion
Mar 2004
Last update
Jan 13, 2010

Study contacts

Rogerio S Silva, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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