Comparison Between Standard Treatment by Continuous Positive Airway Pressure (CPAP) and CPAP Combined to a Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension: The RAP Randomized Controlled Trial

This study is currently recruiting participants.
Verified January 2014 by AGIR à Dom
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
AGIR à Dom
ClinicalTrials.gov Identifier:
NCT02057783
First received: February 4, 2014
Last updated: February 6, 2014
Last verified: January 2014
  Purpose
  1. Sleep apnea syndrome, resistant hypertension and cardio-vascular risk. There are many epidemiological and clinical cohort studies demonstrating an increasing cardiovascular risk associated with Obstructive Sleep Apnea Syndrome (OSAS). In epidemiological studies, OSA severity and incident hypertension are linked in a dose-response fashion. This is true even when taking into account usual confounding factors such as age, alcohol, tobacco consumption and body mass index. More specifically, OSAS is the leading cause of refractory hypertension and OSAS prevalence is up to 80% in patients with resistant hypertension.
  2. CPAP treatment impact for reducing blood pressure in OSAS patients with resistant hypertension A recent small sample size randomized trial (n=35) demonstrated the positive impact of CPAP in decreasing both clinical and 24-hour ambulatory blood pressure. Compared to the control group, awake systolic/diastolic ambulatory blood pressure monitoring decreased significantly in the continuous positive airway pressure group (Delta: +3.1±3.3 /+2.1±2.7 vs. -6.5±3.3/ 4.5±1.9mmHg in control and CPAP groups respectively, p<0.05). Interestingly, the blood pressure changes were only observed while patients were awake, but not during nocturnal ambulatory blood pressure monitoring (Delta: +2.8±4.5/+1.8±3.5 vs. +1.6±3.5/+0.8±2.9mmHg, p=NS).

    HIPARCO Study, the largest Randomized Clinical Trial (RCT) in the field (n=194) recently published in JAMA (9 December 2013) also showed a significant but limited impact of CPAP on blood pressure. In an Intention To Treat analysis, CPAP significantly improved 24-h mean BP (3.0 mmHg; 95% CI 0.3 to 5.8; p=0.031) and DBP (3.2 mmHg; 95% CI 1.0 to 5.4; p=0.005) but not SBP (3.1; 95% CI -0.6 to 6.7; p=0.098). Moreover, patients in the CPAP group had 2.4 (1.2-5.1; p=0.019) times greater probability of recovering their dipper pattern. As CPAP alone is not enough in OSAS to sufficiently improve BP, further studies should address the efficacy of combined therapies in OSAS patients with resistant hypertension.

  3. Resistant hypertension and physical activity A study has recently explored the impact of a standardized exercise program in patients suffering from resistant hypertension7. In this RCT, the authors have demonstrated that the group of patients who have benefit from a physical activity program had their systolic and diastolic 24-hour ambulatory blood pressure monitoring decreasing by 6±12 and 3±7 mmHg respectively(p=0.03). Thus, the physical activity implemented in this population enabled a better control of blood pressure values. However the authors do not give any information about the presence of the absence of Sleep Apnea Syndrome (SAS) in this cohort.
  4. Study hypothesis:

Investigators hypothesize that CPAP treatment for suppressing OSAS in combination with a physical activity program will optimize 24-hour blood pressure control in patients with OSA-related resistant hypertension.

Originality: Up to now no study has assessed the effects of combining physical activity with CPAP treatment in patients with sleep apnea and resistant hypertension. Our work is will be the first aiming at evaluating the benefit of this combination on the control of the systolic blood arterial pressure.


Condition Intervention
Resistant Hypertension
Sleep Apnea
Other: Physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by AGIR à Dom:

Primary Outcome Measures:
  • Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]
  • Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]
  • Change in physical activity: number of hour per day of physical activity [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]
  • pulse wave velocity [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]
  • Change in physical activity : Metabolic Equivalents (METS) [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]
  • Change in physical activity : Number of steps per day [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]
  • Change in sleep duration: Sleep to lying position duration ratio [ Time Frame: To baseline at 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity
Obstructive sleep apnea and resistant hypertension controlled + physical activity
Other: Physical activity
Physical activity will carry out 3 times per week during 12 weeks for intervention arm
No Intervention: Control Group
Obstructive sleep apnea and resistant hypertension controlled

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient with an obstructive sleep apnea (apnea-hypopnea index > or equal to 15)
  • Patient with resistant hypertension uncontrolled by 3 or more antihypertensive agents
  • Ambulatory patient

Exclusion Criteria:

  • Acute hepatic failure, biliary cirrhosis, cholestasis
  • Acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg)
  • Contraindication to CPAP treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02057783

Contacts
Contact: Jean-Louis Pépin, MD PhD JPepin@chu-grenoble.fr
Contact: Olivier Contal, PhD olivier.contal@hesav.ch

Locations
France
Hopital Universitaire de Grenoble Recruiting
Grenoble, France
Contact: Jean-Louis Pépin, MD PhD       JPepin@chu-grenoble.fr   
Contact: Olivier Contal, PhD       olivier.contal@hesav.ch   
Principal Investigator: Jean-Louis Pépin, MD PhD         
Switzerland
Hopitaux Universitaires de Genève Not yet recruiting
Genève, Switzerland
Contact: Jean-Paul Janssens, MD PD       jean-paul.janssens@hcuge.ch   
Sub-Investigator: Jean-Paul Janssens, MD PD         
Principal Investigator: Antoinette Pechère, MD PD         
Centre Hospitalier Universitaire Vaudois Not yet recruiting
Lausanne, Switzerland
Contact: Grégoire Wuerzner, MD PD       gregoire.wuerzne@chuv.ch   
Principal Investigator: Grégoire Wuerzner, MD PD         
Sponsors and Collaborators
AGIR à Dom
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis Pépin, MD PhD Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
  More Information

No publications provided

Responsible Party: AGIR à Dom
ClinicalTrials.gov Identifier: NCT02057783     History of Changes
Other Study ID Numbers: 13-agir-04
Study First Received: February 4, 2014
Last Updated: February 6, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014