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Therapeutic Areas: Neurology | Pulmonary/Respiratory Diseases | Psychiatry/Psychology
Disease Category: Sleep Apnea Syndromes
Trial Information
A Study of the Effect of CPAP in Patients With Diastolic Heart Failure and Sleep-Related Breathing Disorder.
Status: Recruiting
Protocol Number: RD000000388
Sponsor:
Company Division: Diagnostic
Official Scientific Title: Evaluation of the efficacy of treatment with CPAP (continuous postive airway pressure) in patients with diastolic HF (HF with systolic function preserved) and sleep-related breathing disorder.
Brief Summary: This study will evaluate the efficacy of treatment with continuous postive airway pressure (as assessed by measurement of NT-proBNP and a number of echocardiographic variables) in patients with diastolic heart failure and sleep-related breathing disorders. The effect of reversing signs of diastolic dysfunction on long term prognosis in these patients will be evaluated.
Study Phase: N/A
Study Design / Study Details:
- Purpose:
- Allocation: Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Parallel
- Endpoints:
Study Type:
Condition: Sleep Apnea Syndromes
Intervention Type: Diagnostic Test
Intervention Name: ELECSYS®proBNP
Primary Outcome:
Key Secondary Outcomes:
Inclusion Criteria:
- >=1 documented episode of heart failure;
- clinically stable;
- no change of treatment in the month prior to inclusion in the study;
- presence of >=2 abnormal diastolic function indices.
Exclusion Criteria:
- base rhythm different from normal sinus rhythm;
- severe lung disease;
- significant primary heart disease;
- unstable angina pectoris, acute myocardial infarction or heart surgery in 3 months prior to inclusion in study.
Gender: Males or Females
Age Limits: Min: 40 Years Max: 80 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: February, 2006
Trial Registration Date: 12/06/2006
Date Last Updated: 12/08/2006
Link To Trial Results
E-mail: genentechclinicaltrials@druginfo.com
Research Site:
Located In:
Porto 4200-319
Portugal
Phone: 888-662-6728 (U.S. Only)
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