SATELIT-HF: Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients

Sponsor

French Cardiology Society (Other)

Overall Status

Completed

CT.gov ID

NCT01120548

Collaborator

ResMed (Industry), ResMed Foundation (Other), Adep Assistance (Other)

300

Enrollment

Locations

Arms

Duration (Months)

15.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Sleep Disordered Breathing	Other: ventilation therapy	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Peak VO2 [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 [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.

Secondary Outcome Measures

Physical training compliance [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who have NYHA class II to IIIb heart failure, operated or not, ischemic or not, without significant valve pathology.
Referred to cardiac rehabilitation
With an EF < 40%
And an apnea-hypopnea index > 15/h (determined by a nasal flow recording method)
Have signed the consent document to participate in the study.

Exclusion Criteria:

Patients who have been stabilised for less than 10 days (inotropic drugs or modification of the anticipated resynchronisation or PM parameters)
Patients who already use sleep disordered breathing devices
Resting SBP < 80 mmHg (averaged over 3 separate measurements)
Recent angioplasty (within the last 10 days)
Infarction within the last 10 days
Heart surgery within the last 15 days
Valve dysfunction requiring surgery
Uncontrolled high blood pressure (BP > 180 and/or 110 mmHg)
Anaemia (Hb < 9g/dl)
Haemodialysis
Patient receiving circulatory assistance
Severe chronic respiratory failure (FEV1 < 1000) or hypercapnia greater than 46 mmHg
Patient incapable of performing a 6 minute walk test and an exercise test
Absolute contraindication for an exercise test and/or physical training according to the recommendations of the French Society of Cardiology
Evolving myopericarditis
Severe ventricular rhythm disorders that do not stabilise with treatment

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Médical de Bligny	Briis sous Forges	France	91640
2	Clinique de Châtillon	Châtillon	France	92320
3	Hôpital Albert Chenevier	Créteil	France	94000
4	Dieulefit Santé	Dieulefit	France	26220
5	Hôpital Arthur Gardiner	Dinard	France	35800
6	Clinique de cardiopneumologie	Durtol	France	63830
7	Hôpital Sud - Institut de Rééducation	Echirolles	France	38130
8	Hôpital Corentin Celton	Issy-les-moulineaux	France	92133
9	Clinique de La Mitterie	Lomme	France	59160
10	Centre IRIS	Marcy l'Etoile	France	69280
11	Centre Cardio-Vasculaire Valmante	Marseille	France	13009
12	Clinique de réadaptation cardiaque Cardiocéan	Puilboreau	France	17138
13	Hôpital Nord 6	Saint Etienne	France	42055
14	Hôpital Intercommunal Sud Léman Valserine	Saint Julien en Genevois	France	74164
15	Centre William Harvey - le Haut Boscq	Saint Martin d'Aubigny	France	50190
16	Centre de réadaptation cardiaque Leopold Bellan	Tracy le Mont	France	60170
17	Institut Régional de Réadaptation	Vandoeuvre-les-Nancy	France	54500
18	La Maison du Mineur	Vence	France	06140
19	Centre Hospitalier Calmette	Yerres	France	91330