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Completed

NCT Number: NCT01120548

Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients

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.

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Key information

Conditions

Heart Failure Apnea Cardiovascular Diseases Dyssomnias Heart Diseases Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disordered Breathing Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Médical de Bligny, Briis-sous-Forges, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ventilation therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Collaborators

  • Adep Assistance
  • ResMed
  • ResMed Foundation

Registry information

Official study 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

Acronym: SATELIT-HF

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 11, 2010
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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