Status:
UNKNOWN
Sleep Disordered Breathing in Patients With Chronic Heart Failure
Lead Sponsor:
LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology
Conditions:
Sleep-disordered Breathing
Chronic Heart Failure
Eligibility:
All Genders
18-80 years
Brief Summary
Only few prospective studies systematically investigated the prevalence of sleep disordered breathing in patients with stable chronic heart failure. Furthermore there is no report on the incidence rat...
Detailed Description
Chronic heart failure is a complex clinical syndrome that can result from any structural or functional cardiac or non-cardiac disorder that impairs the ability of the heart to respond to physiological...
Eligibility Criteria
Inclusion
- Stable chronic heart failure(NYHA II-IV), defined as
- a condition diagnosed for at least 6 months prior to inclusion under maximally tolerated medical therapy
- without any relevant changes to symptoms or medication during the 8 weeks prior to inclusion
- by the absence of any hospitalizations during the previous 3 month
- Ejection fraction equal or below 35%
- Age between 18 and 80 years
Exclusion
- Instable angina pectoris
- Acute coronary syndrome within the last 6 months
- Cerebrovascular events (TIA, PRIND, stroke) within the last 12 months
- Primary pulmonary hypertension(systolic PAP \> 45 mmHg)
- Congenital heart failure
- Primary heart valve disease
- Regular use of benzodiazepines, other sedatives, or opiate derivatives
- Severe renal(s-creatinine \> 3 mg/dl) and/or liver disease(GPT \> 3xULN)
- Clinically relevant affections of the central nervous system(e.g.epilepsy, multiple sclerosis,...)
- Known moderate to severe chronic obstructive pulmonary disease(FEV1/(F)VC \< 70% und FEV1 \< 50% Soll) or restrictive lung disease with total lung capacity \< 70%
- Untreated hormonal disease(e.g.hypothyreosis,....)
- Daily alcohol consumption with more than 60g alcohol per day for men and more than 30g alcohol per day for women
- Implantation of a pacemaker or ICD within the previous 6 months
- St.p. aortocoronary bypass surgery or lung resection within the previous 12 month
- Women of child-bearing age
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00863421
Start Date
September 1 2008
End Date
May 1 2012
Last Update
June 16 2011
Active Locations (1)
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1
Otto Wagner Hospital
Vienna, Vienna, Austria, 1140