- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047787
Breathing Disorders in Patients With Congestive Heart Failure
Breathing Disorders in Patients With Congestive Heart Failure: Gender and Mortality Impact
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CHF Patients
Congestive Heart Failure Patients
|
examination for sleep disorders
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rogerio S Silva, PhD, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 823/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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