Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients (SATELIT-HF)
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|ClinicalTrials.gov Identifier: NCT01120548|
Recruitment Status : Completed
First Posted : May 11, 2010
Last Update Posted : March 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Sleep Disordered Breathing||Other: ventilation therapy||Not Applicable|
Controlled, randomised, multicentre study. Patients will be assessed prior to starting the rehabilitation programme with regard to exercise tolerance parameters (cardiopulmonary exercise test, 6 minute walk test), ultrasound parameters and biological parameters (Na, Hb, BNP).
The cardiac rehabilitation programme will include education, secondary prevention and physical training components in each of the two groups. The physical training component will include a minimal "base" of activities that is identical for both groups. The nocturnal therapy device will be adapted to the type of SDB specific to each patient (central, mixed, obstructive). The randomisation will be stratified by centre according to predictive factors for performance improvement during rehabilitation.
The main objective is to evaluate the improvement in physical performance resulting from adapted ventilation on SDB compared to physical training alone in patients with heart failure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||SLEEP DISORDERED BREATHING DURING CARDIAC REHABILITATION A Study of the Improvement in Physical Performance of Patients With Heart Failure During Cardiac Rehabilitation Due to the Correction of Sleep Disordered Breathing|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Rehabilitation + Ventilation Group
Patient Heart Failure with sleep disordered breathing who follows ventilation therapy and physical training.
Other: ventilation therapy
The service provider will provide the patient with the ventilation device and will explain to the patient how to operate the device and how to fit the mask according to the specifications.
There will be an oximetry recording during ventilation on the first night. After the first night, the ventilation parameters recorded by the machine and the oximetry results will be read and used to adjust the settings.
Starting the first week and at the end of the programme, the following ventilation parameters will be collected: compliance, leaks, AHI, ventilation mode, pressures used. The threshold of length of nocturnal ventilation fixed to 3h per night on average in order to consider a compliant patient.
|No Intervention: Rehabilitation Only Group|
- Peak VO2 [ Time Frame: Day 1 ]The primary endpoint is the relative improvement of exercise tolerance, estimated using the changes in the patient's peak VO2 measured before starting and after finishing the rehabilitation programme between the both group.
- Peak VO2 [ Time Frame: Between 4 to 9 weeks ]The primary endpoint is the relative improvement of exercise tolerance, estimated using the changes in the patient's peak VO2 measured before starting and after finishing the rehabilitation programme between the both group.
- Physical training compliance [ Time Frame: between 4 and 9 weeks ]Secondary endpoints include compliance with rehabilitation sessions, estimated by comparing the number of sessions in which training was effectively carried out with the anticipated number of sessions and other exercise tolerance parameters (maximum power, duration of exercise, submaximal parameters) in each group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120548
|Centre Médical de Bligny|
|Briis sous Forges, France, 91640|
|Clinique de Châtillon|
|Châtillon, France, 92320|
|Hôpital Albert Chenevier|
|Créteil, France, 94000|
|Dieulefit, France, 26220|
|Hôpital Arthur Gardiner|
|Dinard, France, 35800|
|Clinique de cardiopneumologie|
|Durtol, France, 63830|
|Hôpital Sud - Institut de Rééducation|
|Echirolles, France, 38130|
|Hôpital Corentin Celton|
|Issy-les-moulineaux, France, 92133|
|Clinique de La Mitterie|
|Lomme, France, 59160|
|Marcy l'Etoile, France, 69280|
|Centre Cardio-Vasculaire Valmante|
|Marseille, France, 13009|
|Clinique de réadaptation cardiaque Cardiocéan|
|Puilboreau, France, 17138|
|Hôpital Nord 6|
|Saint Etienne, France, 42055|
|Hôpital Intercommunal Sud Léman Valserine|
|Saint Julien en Genevois, France, 74164|
|Centre William Harvey - le Haut Boscq|
|Saint Martin d'Aubigny, France, 50190|
|Centre de réadaptation cardiaque Leopold Bellan|
|Tracy le Mont, France, 60170|
|Institut Régional de Réadaptation|
|Vandoeuvre-les-Nancy, France, 54500|
|La Maison du Mineur|
|Vence, France, 06140|
|Centre Hospitalier Calmette|
|Yerres, France, 91330|
|Principal Investigator:||Sonia Corone, MD||Centre Médical de Bligny|
|Principal Investigator:||Marie-Christine Iliou, MD||Hôpital Corentin Celton|