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Hypertension, Resistant to Conventional TherapyRAPNCT02057783

Physical Activity Program for Reducing Blood Pressure in Sleep Apnea Patients With Resistant Hypertension

A study testing Physical activity in people with Hypertension, Resistant to Conventional Therapy and Sleep Apnea, run by AGIR à Dom at 5 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Physical activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
5 sitesin 3 countries
Study dates
26 Mar 2015to 18 Feb 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Acute hepatic failure, biliary cirrhosis, cholestasis
  • Acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg)
  • Contraindication to CPAP treatment

Trial locations and contacts

5 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Jean-Louis Pépin, Pr MD PhD contact

JPepin@chu-grenoble.fr

Sandrine Bouzon contact

sbouzon@chu-grenoble.fr

5 sites in 3 countries

France2 sites, 2 recruiting
  • Hopital Universitaire de Grenoble

    La Tronche, 38700

    Jean-Louis Pépin, MD PhD, JPepin@chu-grenoble.fr

    Sandrine Bouzon, sbouzon@chu-grenoble.fr

    Recruiting
  • Clinique Pasteur

    Toulouse, 31300

    Atul Pathak, MD PhD, +33 5 62 21 21 14, apathak@clinique-pasteur.com

    Atul Pathak, MD PhD

    Recruiting

Other trials in France

Switzerland2 sites
  • Hopitaux Universitaires de Genève

    Geneva

    Withdrawn
  • Centre Hospitalier Universitaire Vaudois

    Lausanne

    Withdrawn

Other trials in Switzerland

Canada1 site, 1 recruiting
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

    Québec

    Simon Gakwaya, Simon.Gakwaya@criucpq.ulaval.ca

    Caroline Minville, MD

    Recruiting

Other trials in Canada

About this study

Official title: Comparison of 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: RAP Randomized Controlled Trial

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.

Read the detailed 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.

Being tested
Physical activity
Medical subject headings
Hypertension Resistant to Conventional Therapy, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical activityOther

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

Study groups in NCT02057783
Study groupRoleWhat they receive
Physical activityExperimentalObstructive sleep apnea and resistant hypertension controlled + physical activity
Receives: Other: Physical activity
Control GroupNo interventionObstructive sleep apnea and resistant hypertension controlled

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Measured: To baseline at 12 weeks

Secondary outcomes (7)
  1. diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Measured: To baseline at 12 weeks

  2. Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring

    Measured: To baseline at 12 weeks

  3. Change in physical activity: number of hour per day of physical activity

    Change in physical activity: number of hour per day of physical activity

    Measured: To baseline at 12 weeks

  4. pulse wave velocity

    pulse wave velocity

    Measured: To baseline at 12 weeks

  5. Change in physical activity : Metabolic Equivalents (METS)

    Change in physical activity : Metabolic Equivalents (METS)

    Measured: To baseline at 12 weeks

  6. Change in physical activity : Number of steps per day

    Change in physical activity : Number of steps per day

    Measured: To baseline at 12 weeks

  7. Change in sleep duration: Sleep to lying position duration ratio

    Change in sleep duration: Sleep to lying position duration ratio

    Measured: To baseline at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2014 (estimated)
  2. Study start26 Mar 2015
  3. Primary completion18 Feb 2025 (estimated)
  4. Study completion18 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02057783
Sponsor's protocol ID
13-AGIR-04
Acronym
RAP
Status last verified
Feb 2025
First submitted
4 Feb 2014
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Physical activity in people with Hypertension, Resistant to Conventional Therapy and Sleep Apnea, run by AGIR à Dom at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France, Switzerland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean-Louis Pépin, Pr MD PhD (JPepin@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring (time frame: To baseline at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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