Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120548
• Other study ID #: 2008-07
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: March 6, 2015
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: French Cardiology Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure
• Respiratory Aspiration
• Sleep Disordered Breathing

Intervention

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.

Locations

Country	Name	City	State
France	Centre Médical de Bligny	Briis sous Forges
France	Clinique de Châtillon	Châtillon
France	Hôpital Albert Chenevier	Créteil
France	Dieulefit Santé	Dieulefit
France	Hôpital Arthur Gardiner	Dinard
France	Clinique de cardiopneumologie	Durtol
France	Hôpital Sud - Institut de Rééducation	Echirolles
France	Hôpital Corentin Celton	Issy-les-moulineaux
France	Clinique de La Mitterie	Lomme
France	Centre IRIS	Marcy l'Etoile
France	Centre Cardio-Vasculaire Valmante	Marseille
France	Clinique de réadaptation cardiaque Cardiocéan	Puilboreau
France	Hôpital Nord 6	Saint Etienne
France	Hôpital Intercommunal Sud Léman Valserine	Saint Julien en Genevois
France	Centre William Harvey - le Haut Boscq	Saint Martin d'Aubigny
France	Centre de réadaptation cardiaque Leopold Bellan	Tracy le Mont
France	Institut Régional de Réadaptation	Vandoeuvre-les-Nancy
France	La Maison du Mineur	Vence
France	Centre Hospitalier Calmette	Yerres

Sponsors (4)

Lead Sponsor	Collaborator
French Cardiology Society	Adep Assistance, ResMed, ResMed Foundation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1	No
Primary	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.	Between 4 to 9 weeks	No
Secondary	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.	between 4 and 9 weeks	No