Cardiac Function After CPAP Therapy in Patients With Chronic Heart Failure and Sleep Apnea. A Multicenter Study
Primary Purpose
Sleep Apnea, Heart Failure, Cardiovascular Diseases
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CPAP(Continuous Positive Airway Pressure)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea focused on measuring Continuous positive airway pressure, cardiovascular diseases, sleep apnea syndromes, sleep breathing disorders, sham CPAP
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Hospital Universitario Txagorritxu
Outcomes
Primary Outcome Measures
Ejection fraction
Secondary Outcome Measures
Hypertension
Daytime sleepiness
Quality of life (SF-36)
NewYork Heart Scale (NYHA score),
Dyspnea (by using the Borg scale)
Exercise tolerance (6-min WT
Full Information
NCT ID
NCT00404807
First Posted
November 28, 2006
Last Updated
November 28, 2006
Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Fondo de Investigacion Sanitaria, Sociedad Vasco-Navarra de Patología Respiratoria, RESPIRA
1. Study Identification
Unique Protocol Identification Number
NCT00404807
Brief Title
Cardiac Function After CPAP Therapy in Patients With Chronic Heart Failure and Sleep Apnea. A Multicenter Study
Official Title
Cardiac Function After CPAP Therapy in Patients With Chronic Heart Failure and Sleep Apnea. A Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Terminated
Study Start Date
January 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Collaborators
Fondo de Investigacion Sanitaria, Sociedad Vasco-Navarra de Patología Respiratoria, RESPIRA
4. Oversight
5. Study Description
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 respiratory sleep disorders in CHF could slow down deterioration or improve the cardiovascular function.
In an attempt to yield further insight into this subject, we undertook a multicentre study to analyze the role of CPAP therapy (optimal vs sham) in the LVEF and in other cardiac measurements in patients with CHF.Aim. We evaluated in a randomized multicentre placebo (sham-CPAP) controlled study the effect of CPAP treatment on the left ventricle ejection fraction (LVEF) among other cardiological related variables.
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 explorations, 127 out of 245 fulfilled the rigid inclusion and exclusion criteria in order to have CHF subjects without obvious comorbidity (see flowchart of figure 1). These subjects went to full (polysomnography) PSG. Fifty seven per cent of them (n: 73) had an apnea hypopnea index (AHI) > 10. Forty three per cent (n:54) had an AHI < 10. Only 17% of the patients had CSA. The selection and inclusion criteria used for recruitment were the following: 1) referral of patients with chronic heart failure to the sleep laboratory; 2) diagnosis of heart failure with at least one episode of cardiac failure; 3) LVEF less than 45% using radionuclide ventriculography; 4) clinical stability for at least one month prior to inclusion; 5) optimum treatment with diuretics and/or beta-blockers and/or digoxin and/or ACE inhibitors according to tolerance 6) no change in treatment for one month prior to inclusion; and 7) an Apnea-Hypopnea Index (AHI) greater than 10 measured by conventional polysomnography. The exclusion criteria were as follows: 1) patients that had a previous diagnosis of OSA or had been exposed to CPAP therapy. 2) uncontrolled arterial hypertension; 3) valvular or congenital cardiopathy, unstable angina, acute myocardial infarction or cardiac surgery in the three months prior to enrolment; 4) severe somnolence defined as severe sleepiness in situations of activity; 5) present or past medical history of clinically significant renal, liver or pulmonary disease; 6) untreated hypothyroidism; 7) clinically significant kyphoscoliosis; 8) morbid obesity with a body mass index (BMI)> 41 Kg/m2; and 9) concomitant use of the following drugs: morphine, hypnotics and sedatives, theophylline, acetazolamide or home oxygen therapy. Informed written consent was obtained from all subjects. This study was approved by the Human Ethics Committee of the 8 centres.
The subjects selected were randomized to receive CPAP or sham CPAP (Figure 1). They were evaluated at baseline (before any intervention) and after three months of follow-up. The assessment was performed on the basis of a LVEF. In addition, hypertension, subjective daytime sleepiness(sleepiness scale [ESS] (17), quality of life questionnaire according to the Spanish version of the SF-36 were also studied (18) The answers of the SF-36 were codified and divided into two groups, physical (PCS) and mental (MCS) with eight subclasses (physical function, physical role, bodily pain, general health, vitality, social function, emotional role, mental health). Other measurements were: dyspnea using the Borg scale (19), the New York Heart Association scale (NYHA scale), and the 6-minute walking test (20-21). The obstructive group accounting for 83% of all the patients were also studied. CPAP and sham CPAP compliance were recorded by a built-in device in the machine and registered at 4 weeks and at the end of the treatment period. After one month of treatment, another PSG was performed to re-assess the AHI. All visits were registered in a database on an encrypted website of the homepage of the Basque Health Service
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Heart Failure, Cardiovascular Diseases
Keywords
Continuous positive airway pressure, cardiovascular diseases, sleep apnea syndromes, sleep breathing disorders, sham CPAP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
245 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CPAP(Continuous Positive Airway Pressure)
Primary Outcome Measure Information:
Title
Ejection fraction
Secondary Outcome Measure Information:
Title
Hypertension
Title
Daytime sleepiness
Title
Quality of life (SF-36)
Title
NewYork Heart Scale (NYHA score),
Title
Dyspnea (by using the Borg scale)
Title
Exercise tolerance (6-min WT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Egea-Santaolalla, MD
Organizational Affiliation
Hospital Universitario Txagorritxu. Vitoria Gasteiz. Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Txagorritxu
City
Vitoria Gasteiz
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Cardiac Function After CPAP Therapy in Patients With Chronic Heart Failure and Sleep Apnea. A Multicenter Study
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