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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02057783
Other study ID # 13-AGIR-04
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 26, 2015
Est. completion date July 2019

Study information

Verified date June 2018
Source AGIR à Dom
Contact Jean-Louis Pépin, Pr MD PhD
Email JPepin@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical activity
Physical activity will carry out 3 times per week during 12 weeks for intervention arm

Locations

Country Name City State
Canada Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) Québec
France Hopital Universitaire de Grenoble La Tronche
France Clinique Pasteur Toulouse
Switzerland Hopitaux Universitaires de Genève Genève
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne

Sponsors (2)

Lead Sponsor Collaborator
AGIR à Dom University Hospital, Grenoble

Countries where clinical trial is conducted

Canada,  France,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring To baseline at 12 weeks
Secondary diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring To baseline at 12 weeks
Secondary Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring To baseline at 12 weeks
Secondary Change in physical activity: number of hour per day of physical activity Change in physical activity: number of hour per day of physical activity To baseline at 12 weeks
Secondary pulse wave velocity pulse wave velocity To baseline at 12 weeks
Secondary Change in physical activity : Metabolic Equivalents (METS) Change in physical activity : Metabolic Equivalents (METS) To baseline at 12 weeks
Secondary Change in physical activity : Number of steps per day Change in physical activity : Number of steps per day To baseline at 12 weeks
Secondary Change in sleep duration: Sleep to lying position duration ratio Change in sleep duration: Sleep to lying position duration ratio To baseline at 12 weeks
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