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

French Cardiology Society

Status

Completed

Conditions

Sleep Disordered Breathing

Heart Failure

Treatments

Other: ventilation therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01120548

2008-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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