Heart FailureSATELIT-HFNCT01120548
Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients
A study testing ventilation therapy in people with Heart Failure and Sleep Disordered Breathing, run by French Cardiology Society at 19 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Sleep Disordered Breathing
- What is being tested?
- ventilation therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 19 sitesFrance
- Study dates
- Sep 2010to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Centre Médical de Bligny
Briis-sous-Forges, 91640
Clinique de Châtillon
Châtillon, 92320
Hôpital Albert Chenevier
Créteil, 94000
Dieulefit Santé
Dieulefit, 26220
Hôpital Arthur Gardiner
Dinard, 35800
Clinique de cardiopneumologie
Durtol, 63830
Hôpital Sud - Institut de Rééducation
Échirolles, 38130
Hôpital Corentin Celton
Issy-les-Moulineaux, 92133
Clinique de La Mitterie
Lomme, 59160
Centre IRIS
Marcy-l'Étoile, 69280
Centre Cardio-Vasculaire Valmante
Marseille, 13009
Clinique de réadaptation cardiaque Cardiocéan
Puilboreau, 17138
Hôpital Nord 6
Saint-Etienne, 42055
Hôpital Intercommunal Sud Léman Valserine
Saint-Julien-en-Genevois, 74164
Centre William Harvey - le Haut Boscq
Saint-Martin-d'Aubigny, 50190
Centre de réadaptation cardiaque Leopold Bellan
Tracy-le-Mont, 60170
Institut Régional de Réadaptation
Vandœuvre-lès-Nancy, 54500
La Maison du Mineur
Vence, 06140
Centre Hospitalier Calmette
Yerres, 91330
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure, Sleep Disordered Breathing
- Being tested
- ventilation therapy
- Keywords
- CARDIAC REHABILITATION, Nocturnal Ventilation, Apnea hypopnea index is > 15/h
- Medical subject headings
- Heart Failure, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilation therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation + Ventilation Group | Experimental | Patient Heart Failure with sleep disordered breathing who follows ventilation therapy and physical training. Receives: Other: ventilation therapy |
| Rehabilitation Only Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
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.
Measured: Between 4 to 9 weeks
Secondary outcomes (1)
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.
Measured: between 4 and 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- ResMed, ResMed Foundation, Adep Assistance
- Responsible party
- Sponsor
- Investigators
- Sonia Corone, MD, Principal investigator, Centre Médical de BlignyMarie-Christine Iliou, MD, Principal investigator, Hôpital Corentin Celton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120548
- Sponsor's protocol ID
- 2008-07
- Acronym
- SATELIT-HF
- Status last verified
- Mar 2015
- First submitted
- 6 May 2010
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01120548
- Acronym / sponsor ID
- SATELIT-HF / 2008-07
- Conditions
- Heart Failure, Sleep Disordered Breathing
- Keywords
- CARDIAC REHABILITATION, Nocturnal Ventilation, Apnea hypopnea index is > 15/h
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- ResMed, ResMed Foundation, Adep Assistance
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation + Ventilation Group | Experimental | Other: ventilation therapyPatient Heart Failure with sleep disordered breathing who follows ventilation therapy and physical training. |
| Rehabilitation Only Group | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventilation therapyThe 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. | Other | Rehabilitation + Ventilation Group |
Primary outcome
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.
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.
1 secondary outcome
Physical training compliance
Time frame: between 4 and 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia Corone, MD principal investigator
Centre Médical de Bligny
Marie-Christine Iliou, MD principal investigator
Hôpital Corentin Celton
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilation therapy in people with Heart Failure and Sleep Disordered Breathing, run by French Cardiology Society at 19 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.