Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ResMed
ResMed Foundation
Adep Assistance
Information provided by (Responsible Party):
French Cardiology Society
ClinicalTrials.gov Identifier:
NCT01120548
First received: May 6, 2010
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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 Intervention
Heart Failure
Sleep Disordered Breathing
Other: ventilation therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by French Cardiology Society:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 300
Study Start Date: September 2010
Estimated Study Completion Date: November 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120548

Locations
France
Centre Médical de Bligny
Briis sous Forges, France, 91640
Clinique de Châtillon
Châtillon, France, 92320
Hôpital Albert Chenevier
Créteil, France, 94000
Dieulefit Santé
Dieulefit, France, 26220
Hôpital Arthur Gardiner
Dinard, France, 35800
Clinique de cardiopneumologie
Durtol, France, 63830
Hôpital Sud - Institut de Rééducation
Echirolles, France, 38130
Hôpital Corentin Celton
Issy-les-moulineaux, France, 92133
Clinique de La Mitterie
Lomme, France, 59160
Centre IRIS
Marcy l'Etoile, France, 69280
Centre Cardio-Vasculaire Valmante
Marseille, France, 13009
Clinique de réadaptation cardiaque Cardiocéan
Puilboreau, France, 17138
Hôpital Nord 6
Saint Etienne, France, 42055
Hôpital Intercommunal Sud Léman Valserine
Saint Julien en Genevois, France, 74164
Centre William Harvey - le Haut Boscq
Saint Martin d'Aubigny, France, 50190
Centre de réadaptation cardiaque Leopold Bellan
Tracy le Mont, France, 60170
Institut Régional de Réadaptation
Vandoeuvre-les-Nancy, France, 54500
La Maison du Mineur
Vence, France, 06140
Centre Hospitalier Calmette
Yerres, France, 91330
Sponsors and Collaborators
French Cardiology Society
ResMed
ResMed Foundation
Adep Assistance
Investigators
Principal Investigator: Sonia Corone, MD Centre Médical de Bligny
Principal Investigator: Marie-Christine Iliou, MD Hôpital Corentin Celton
  More Information

No publications provided

Responsible Party: French Cardiology Society
ClinicalTrials.gov Identifier: NCT01120548     History of Changes
Other Study ID Numbers: 2008-07
Study First Received: May 6, 2010
Last Updated: October 8, 2014
Health Authority: France: Ministry of Health

Keywords provided by French Cardiology Society:
CARDIAC REHABILITATION
Nocturnal Ventilation
Apnea hypopnea index is > 15/h

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 24, 2014