Clinical trial NCT01120548: Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Sleep Disordered Breathing
Keywords: CARDIAC REHABILITATION
Nocturnal Ventilation
Apnea hypopnea index is > 15/h
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
Collaborators: name: ResMed
name: ResMed Foundation
name: Adep Assistance
First posted: 2010-05-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Peak VO2
timeFrame: Day 1
measure: Peak VO2
timeFrame: Between 4 to 9 weeks
Secondary outcomes:
measure: Physical training compliance
timeFrame: between 4 and 9 weeks
Other outcomes:
Locations:
city: Briis sous Forges
country: France
facility: Centre Médical de Bligny
city: Châtillon
country: France
facility: Clinique de Châtillon
city: Créteil
country: France
facility: Hôpital Albert Chenevier
city: Dieulefit
country: France
facility: Dieulefit Santé
city: Dinard
country: France
facility: Hôpital Arthur Gardiner
city: Durtol
country: France
facility: Clinique de cardiopneumologie
city: Echirolles
country: France
facility: Hôpital Sud - Institut de Rééducation
city: Issy-les-moulineaux
country: France
facility: Hôpital Corentin Celton
city: Lomme
country: France
facility: Clinique de La Mitterie
city: Marcy l'Etoile
country: France
facility: Centre IRIS
city: Marseille
country: France
facility: Centre Cardio-Vasculaire Valmante
city: Puilboreau
country: France
facility: Clinique de réadaptation cardiaque Cardiocéan
city: Saint Etienne
country: France
facility: Hôpital Nord 6
city: Saint Julien en Genevois
country: France
facility: Hôpital Intercommunal Sud Léman Valserine
city: Saint Martin d'Aubigny
country: France
facility: Centre William Harvey - le Haut Boscq
city: Tracy le Mont
country: France
facility: Centre de réadaptation cardiaque Leopold Bellan
city: Vandoeuvre-les-Nancy
country: France
facility: Institut Régional de Réadaptation
city: Vence
country: France
facility: La Maison du Mineur
city: Yerres
country: France
facility: Centre Hospitalier Calmette
Study officials:
affiliation: Centre Médical de Bligny
name: Sonia Corone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Corentin Celton
name: Marie-Christine Iliou, MD
role: PRINCIPAL_INVESTIGATOR
References: