Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients (SATELIT-HF)
Sleep disordered breathing (SDB) is a frequent comorbidity for heart failure patients. Its prevalence varies according to the seriousness of the condition of the patients, but it is present in approximately 50% of patients. Screening patients for SDB and managing them by providing adapted ventilation therapy should improve their quality of life or even their prognosis. Moreover, SDB lowers nocturnal cardiovascular recovery abilities and leads to an increase in fatigability and, as a result, exercise intolerance in patients with heart failure. Physical training as part of a cardiac rehabilitation programme provides many benefits, including improving patients' exercise capacities. Our hypothesis is that adapted sleep disordered breathing therapy during rehabilitation will lead to an improvement in rehabilitation results.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Peak VO2 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120548
|Contact: Sonia Corone, MD||01 69 26 31 60 ext +email@example.com|
|Contact: Marie-Christine Iliou, MD||01 43 95 94 51 ext +firstname.lastname@example.org|
|Centre Médical de Bligny||Recruiting|
|Briis sous Forges, France, 91640|
|Contact: Sonia Corone, MD 01 69 26 31 60 ext +33 email@example.com|
|Principal Investigator: Sonia Corone, MD|
|Clinique de Châtillon||Recruiting|
|Châtillon, France, 92320|
|Contact: Jean-Louis Bussière, MD (33)01 41 90 21 00 firstname.lastname@example.org|
|Principal Investigator: Jean-Louis Bussière, MD|
|Hôpital Albert Chenevier||Recruiting|
|Créteil, France, 94000|
|Contact: Barnabas Gellen, MD (33)01 49 81 30 21 email@example.com|
|Principal Investigator: Barnabas Gellen, MD|
|Dieulefit, France, 26220|
|Contact: Richard Brion, MD (33)04 75 00 55 00|
|Principal Investigator: Richard Brion, MD|
|Hôpital Arthur Gardiner||Recruiting|
|Dinard, France, 35800|
|Contact: Thierry Denolle, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Thierry Denolle, MD, PhD|
|Clinique de cardiopneumologie||Terminated|
|Durtol, France, 63830|
|Hôpital Sud - Institut de Rééducation||Terminated|
|Echirolles, France, 38130|
|Hôpital Corentin Celton||Recruiting|
|Issy-les-moulineaux, France, 92133|
|Contact: Marie-Christine Iliou, MD 01 43 95 94 51 ext +33 email@example.com|
|Principal Investigator: Marie-Christine Iliou, MD|
|Clinique de La Mitterie||Recruiting|
|Lomme, France, 59160|
|Contact: Jean-Pierre Beugin, MD (33)03 20 22 64 00 firstname.lastname@example.org|
|Principal Investigator: Jean-Pierre Beugin, MD|
|Marcy l'Etoile, France, 69280|
|Centre Cardio-Vasculaire Valmante||Recruiting|
|Marseille, France, 13009|
|Contact: Jean-Etienne Touze, Md,PhD email@example.com|
|Principal Investigator: Jean-Etienne Touze, MD, PhD|
|Clinique de réadaptation cardiaque Cardiocéan||Recruiting|
|Puilboreau, France, 17138|
|Contact: Muriel Bigot, MD (33)05 46 68 47 83 firstname.lastname@example.org|
|Principal Investigator: Muriel Bigot, MD|
|Hôpital Nord 6||Recruiting|
|Saint Etienne, France, 42055|
|Contact: Frédéric Roche, MD (33)04 77 82 83 00 email@example.com|
|Principal Investigator: Frédéric Roche, MD|
|Hôpital Intercommunal Sud Léman Valserine||Terminated|
|Saint Julien en Genevois, France, 74164|
|Centre William Harvey - le Haut Boscq||Terminated|
|Saint Martin d'Aubigny, France, 50190|
|Centre de réadaptation cardiaque Leopold Bellan||Recruiting|
|Tracy le Mont, France, 60170|
|Contact: Mohamed Ghannem, MD (33)03 44 75 50 10 firstname.lastname@example.org|
|Principal Investigator: Mohamed Ghannem, MD|
|Institut Régional de Réadaptation||Terminated|
|Vandoeuvre-les-Nancy, France, 54500|
|La Maison du Mineur||Recruiting|
|Vence, France, 06140|
|Contact: Helene Lescaut, MD email@example.com|
|Principal Investigator: Anne Bellemain-Appaix, MD|
|Centre Hospitalier Calmette||Terminated|
|Yerres, France, 91330|
|Principal Investigator:||Sonia Corone, MD||Centre Médical de Bligny|
|Principal Investigator:||Marie-Christine Iliou, MD||Hôpital Corentin Celton|