Congestive Heart FailureNCT01047787
Breathing Disorders in Patients With Congestive Heart Failure
An observational study of Congestive Heart Failure, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Polysomnography
- How many people
- 89 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to Mar 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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.
Who cannot join
- Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.
About this study
Official title: Breathing Disorders in Patients With Congestive Heart Failure: Gender and Mortality Impact
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Polysomnography
- Keywords
- Sleep apnea, Cheyne-Stokes Respiration, Congestive Heart Failure
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
examination for sleep disorders
| Study group | Role | What they receive |
|---|---|---|
| CHF Patients | Congestive Heart Failure Patients Receives: Other: Polysomnography |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startNov 2001
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rogerio S Silva, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047787
- Sponsor's protocol ID
- 823/01
- Status last verified
- May 2007
- First submitted
- 15 May 2007
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Disorders in Patients With Congestive Heart Failure: Gender and Mortality Impact
- ClinicalTrials.gov ID
- NCT01047787
- Acronym / sponsor ID
- 823/01
- Conditions
- Congestive Heart Failure
- Keywords
- Sleep apnea, Cheyne-Stokes Respiration, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2001
- Study completion
- Mar 2004 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHF Patients | – | Other: PolysomnographyCongestive Heart Failure Patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with neurological, pulmonary, renal, musculoskeletal disease, unstable angina, primary valvular heart disease or previous diagnosis of sleep disordered breathing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysomnographyexamination for sleep disorders | Other | CHF Patients |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogerio S Silva, PhD principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.