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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02317848 |
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Date of registration:
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10/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure
PROVE-SAS-AHF |
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Scientific title:
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PRevalence, Persistence and prOgnostic ValuE of Sleep Apnea Syndrome in Acute Heart Failure. |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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54 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02317848 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Major Patient.
- Acute heart failure (stage II, III Killip) having clinical conditions of the European
Society of Cardiology guidelines 2005 (26: 384-416) regardless of LVEF.
Exclusion Criteria:
- Patients who have not given their consent.
- State of cardiogenic shock.
- SAS known and treated.
- Patients who are not affiliated to a French social security.
- Significant myocardial infarction transmural (ST depression) in the last 3 months.
- Important heart surgery in the last 3 months.
- Resynchronization in the last 3 months.
- Any significant changes in drug or therapy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sleep Apnea Syndrome
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Heart Failure
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Intervention(s)
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Other: polygraphy and ECG
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Primary Outcome(s)
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Persistence of the severity of SAS at the follow visit (AHI> 15).
[Time Frame: 2 months after AHF]
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Secondary Outcome(s)
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type of SAS
[Time Frame: 2 months after AHF]
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Echocardiography parameters ECG Holter, biology
[Time Frame: 2 months after AHF]
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Prognostic at 1 year (mortality and rehospitalization for HF)
[Time Frame: 2 months after AHF]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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