Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients
Condition: Heart Failure; Sleep Disordered Breathing
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Heart Failure
Study type: Interventional

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.
    

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.
    

Intervention name(s): ventilation therapy
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CARDIAC REHABILITATION; Nocturnal Ventilation; Apnea hypopnea index is > 15/h