Trial Information

Summary: 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

Contact:

Research Site:
Located In:
Porto, Portugal, 4200-319
Telephone: 973-235-5000 or 800-526-6367

 

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Trial listings updated: May 13, 2008 at 2:00:10 PM


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