Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients

NCT ID: NCT01120548

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Heart Failure; Sleep Disordered Breathing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Rehabilitation + Ventilation Group

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

Group Type: EXPERIMENTAL

ventilation therapy

Intervention Type: OTHER

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.

Rehabilitation Only Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: collaborator

ResMed Foundation

OTHER

Sponsor Role: collaborator

Adep Assistance

OTHER

Sponsor Role: collaborator

French Cardiology Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonia Corone, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Médical de Bligny

Marie-Christine Iliou, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Corentin Celton

Locations

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

Échirolles, , France

Hôpital Corentin Celton

Issy-les-Moulineaux, , France

Clinique de La Mitterie

Lomme, , France

Centre IRIS

Marcy-l'Étoile, , 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

Vandœuvre-lès-Nancy, , France

La Maison du Mineur

Vence, , France

Centre Hospitalier Calmette

Yerres, , France

Countries

France

Other Identifiers

2008-07

Identifier Type: -

Identifier Source: org_study_id