Status:
TERMINATED
Cardiac Function After CPAP Therapy in Patients With Chronic Heart Failure and Sleep Apnea. A Multicenter Study
Lead Sponsor:
Sociedad Española de Neumología y Cirugía Torácica
Collaborating Sponsors:
Fondo de Investigacion Sanitaria
Sociedad Vasco-Navarra de Patología Respiratoria
Conditions:
Sleep Apnea
Heart Failure
Eligibility:
All Genders
30-85 years
Phase:
NA
Brief Summary
The role of continuous positive airway pressure (CPAP) in cardiac function in patients with CSA and OSA has been studied with varying results. Nevertheless, it is not clear whether CPAP treatment for ...
Detailed Description
From the Cardiologist Department of eight university hospitals CHF patients were referred to the Sleep Units with the sole condition of having a LVEF \< 45%. After an interview and some clinical explo...
Eligibility Criteria
Inclusion
- referral of patients with chronic heart failure to the sleep laboratory;
- diagnosis of heart failure with at least one episode of cardiac failure;
- LVEF less than 45% using radionuclide ventriculography;
- clinical stability for at least one month prior to inclusion;
- optimum treatment with diuretics and/or beta-blockers and/or digoxin and/or ACE inhibitors according to tolerance
- no change in treatment for one month prior to inclusion; and
- an Apnea-Hypopnea Index (AHI) greater than 10 measured by conventional polysomnography
Exclusion
- patients that had a previous diagnosis of OSA or had been exposed to CPAP therapy.
- uncontrolled arterial hypertension;
- valvular or congenital cardiopathy, unstable angina, acute myocardial infarction or cardiac surgery in the three months prior to enrolment;
- severe somnolence defined as severe sleepiness in situations of activity;
- present or past medical history of clinically significant renal, liver or pulmonary disease;
- untreated hypothyroidism;
- clinically significant kyphoscoliosis;
- morbid obesity with a body mass index (BMI)\> 41 Kg/m2; and
- concomitant use of the following drugs: morphine, hypnotics and sedatives, theophylline, acetazolamide or home oxygen therapy
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00404807
Start Date
January 1 2001
End Date
June 1 2004
Last Update
November 29 2006
Active Locations (1)
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1
Hospital Universitario Txagorritxu
Vitoria-Gasteiz, Alava, Spain, 01009