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

Primary Purpose

Heart Failure, Sleep Disordered Breathing

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ventilation therapy
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring CARDIAC REHABILITATION, Nocturnal Ventilation, Apnea hypopnea index is > 15/h

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Médical de Bligny
  • Clinique de Châtillon
  • Hôpital Albert Chenevier
  • Dieulefit Santé
  • Hôpital Arthur Gardiner
  • Clinique de cardiopneumologie
  • Hôpital Sud - Institut de Rééducation
  • Hôpital Corentin Celton
  • Clinique de La Mitterie
  • Centre IRIS
  • Centre Cardio-Vasculaire Valmante
  • Clinique de réadaptation cardiaque Cardiocéan
  • Hôpital Nord 6
  • Hôpital Intercommunal Sud Léman Valserine
  • Centre William Harvey - le Haut Boscq
  • Centre de réadaptation cardiaque Leopold Bellan
  • Institut Régional de Réadaptation
  • La Maison du Mineur
  • Centre Hospitalier Calmette

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rehabilitation + Ventilation Group

Rehabilitation Only Group

Arm Description

Patient Heart Failure with sleep disordered breathing who follows ventilation therapy and physical training.

Outcomes

Primary Outcome Measures

Peak VO2
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
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
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.

Full Information

First Posted
May 6, 2010
Last Updated
March 6, 2015
Sponsor
French Cardiology Society
Collaborators
ResMed, ResMed Foundation, Adep Assistance
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1. Study Identification

Unique Protocol Identification Number
NCT01120548
Brief Title
Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients
Acronym
SATELIT-HF
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
ResMed, ResMed Foundation, Adep Assistance

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Sleep Disordered Breathing
Keywords
CARDIAC REHABILITATION, Nocturnal Ventilation, Apnea hypopnea index is > 15/h

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitation + Ventilation Group
Arm Type
Experimental
Arm Description
Patient Heart Failure with sleep disordered breathing who follows ventilation therapy and physical training.
Arm Title
Rehabilitation Only Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
ventilation therapy
Intervention Description
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 Outcome Measure Information:
Title
Peak VO2
Description
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.
Time Frame
Day 1
Title
Peak VO2
Description
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.
Time Frame
Between 4 to 9 weeks
Secondary Outcome Measure Information:
Title
Physical training compliance
Description
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.
Time Frame
between 4 and 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Corone, MD
Organizational Affiliation
Centre Médical de Bligny
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-Christine Iliou, MD
Organizational Affiliation
Hôpital Corentin Celton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Médical de Bligny
City
Briis sous Forges
ZIP/Postal Code
91640
Country
France
Facility Name
Clinique de Châtillon
City
Châtillon
ZIP/Postal Code
92320
Country
France
Facility Name
Hôpital Albert Chenevier
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Dieulefit Santé
City
Dieulefit
ZIP/Postal Code
26220
Country
France
Facility Name
Hôpital Arthur Gardiner
City
Dinard
ZIP/Postal Code
35800
Country
France
Facility Name
Clinique de cardiopneumologie
City
Durtol
ZIP/Postal Code
63830
Country
France
Facility Name
Hôpital Sud - Institut de Rééducation
City
Echirolles
ZIP/Postal Code
38130
Country
France
Facility Name
Hôpital Corentin Celton
City
Issy-les-moulineaux
ZIP/Postal Code
92133
Country
France
Facility Name
Clinique de La Mitterie
City
Lomme
ZIP/Postal Code
59160
Country
France
Facility Name
Centre IRIS
City
Marcy l'Etoile
ZIP/Postal Code
69280
Country
France
Facility Name
Centre Cardio-Vasculaire Valmante
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Clinique de réadaptation cardiaque Cardiocéan
City
Puilboreau
ZIP/Postal Code
17138
Country
France
Facility Name
Hôpital Nord 6
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Hôpital Intercommunal Sud Léman Valserine
City
Saint Julien en Genevois
ZIP/Postal Code
74164
Country
France
Facility Name
Centre William Harvey - le Haut Boscq
City
Saint Martin d'Aubigny
ZIP/Postal Code
50190
Country
France
Facility Name
Centre de réadaptation cardiaque Leopold Bellan
City
Tracy le Mont
ZIP/Postal Code
60170
Country
France
Facility Name
Institut Régional de Réadaptation
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
La Maison du Mineur
City
Vence
ZIP/Postal Code
06140
Country
France
Facility Name
Centre Hospitalier Calmette
City
Yerres
ZIP/Postal Code
91330
Country
France

12. IPD Sharing Statement

Learn more about this trial

Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients

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