Sleep Apnea Treatment During Cardiac Rehabilitation of Congestive Heart Failure Patients

NCT01120548 | Completed

• 1 other identifier: 2008-07
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 19

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.

Conditions

Heart Failure; Sleep Disordered Breathing

Keywords

CARDIAC REHABILITATION; Nocturnal Ventilation; Apnea hypopnea index is > 15/h

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (1)

• Physical training compliance

  between 4 and 9 weeks

Study Arms (2)

Rehabilitation + Ventilation Group

EXPERIMENTAL

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

Other: ventilation therapy

Rehabilitation Only Group

NO INTERVENTION

Interventions

ventilation therapy 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 + Ventilation Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• French Cardiology Society: lead
• ResMed: collaborator
• ResMed Foundation: collaborator
• Adep Assistance: collaborator

Study Sites (19)

Centre Médical de Bligny

Briis-sous-Forges, 91640, France

Location

Clinique de Châtillon

Châtillon, 92320, France

Location

Hôpital Albert Chenevier

Créteil, 94000, France

Location

Dieulefit Santé

Dieulefit, 26220, France

Location

Hôpital Arthur Gardiner

Dinard, 35800, France

Location

Clinique de cardiopneumologie

Durtol, 63830, France

Location

Hôpital Sud - Institut de Rééducation

Échirolles, 38130, France

Location

Hôpital Corentin Celton

Issy-les-Moulineaux, 92133, France

Location

Clinique de La Mitterie

Lomme, 59160, France

Location

Centre IRIS

Marcy-l'Étoile, 69280, France

Location

Centre Cardio-Vasculaire Valmante

Marseille, 13009, France

Location

Clinique de réadaptation cardiaque Cardiocéan

Puilboreau, 17138, France

Location

Hôpital Nord 6

Saint-Etienne, 42055, France

Location

Hôpital Intercommunal Sud Léman Valserine

Saint-Julien-en-Genevois, 74164, France

Location

Centre William Harvey - le Haut Boscq

Saint-Martin-d'Aubigny, 50190, France

Location

Centre de réadaptation cardiaque Leopold Bellan

Tracy-le-Mont, 60170, France

Location

Institut Régional de Réadaptation

Vandœuvre-lès-Nancy, 54500, France

Location

La Maison du Mineur

Vence, 06140, France

Location

Centre Hospitalier Calmette

Yerres, 91330, France

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sonia Corone, MD

  Centre Médical de Bligny

  PRINCIPAL INVESTIGATOR

• Marie-Christine Iliou, MD

  Hôpital Corentin Celton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 11, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

FR (19)