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.
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
- Conditions the study is for
- Hypertension, Resistant to Conventional Therapy, Sleep Apnea
- 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
Sandrine Bouzon contact
5 sites in 3 countries
France2 sites, 2 recruiting
- 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
Switzerland2 sites
- Withdrawn
Hopitaux Universitaires de Genève
Geneva
- Withdrawn
Centre Hospitalier Universitaire Vaudois
Lausanne
Canada1 site, 1 recruiting
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec
Simon Gakwaya, Simon.Gakwaya@criucpq.ulaval.ca
Caroline Minville, MD
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
- 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.
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Obstructive sleep apnea and resistant hypertension controlled + physical activity Receives: Other: Physical activity |
| Control Group | No intervention | Obstructive sleep apnea and resistant hypertension controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
pulse wave velocity
pulse wave velocity
Measured: To baseline at 12 weeks
Change in physical activity : Metabolic Equivalents (METS)
Change in physical activity : Metabolic Equivalents (METS)
Measured: To baseline at 12 weeks
Change in physical activity : Number of steps per day
Change in physical activity : Number of steps per day
Measured: To baseline at 12 weeks
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.
- First posted7 Feb 2014 (estimated)
- Study start26 Mar 2015
- Primary completion18 Feb 2025 (estimated)
- Study completion18 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, Resistant to Conventional TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, Pr MD PhD, Principal investigator, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02057783
- Acronym / sponsor ID
- RAP / 13-AGIR-04
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble
- Study start
- 26 Mar 2015 (actual)
- Primary completion
- 18 Feb 2025 (estimated)
- Study completion
- 18 Feb 2025 (estimated)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Other: Physical activityObstructive sleep apnea and resistant hypertension controlled + physical activity |
| Control Group | No intervention | –Obstructive sleep apnea and resistant hypertension controlled |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Acute hepatic failure, biliary cirrhosis, cholestasis
- Acute hypertension (SBP>= 180 mmHg and/or DBP >= 110 mmHg)
- Contraindication to CPAP treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityPhysical activity will carry out 3 times per week during 12 weeks for intervention arm | Other | Physical activity |
Primary outcome
Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring
Time frame: To baseline at 12 weeks
Systolic arterial blood pressure assessed by 24-hours home blood pressure monitoring
7 secondary outcomes
diastolic arterial blood pressure assessed by 24-hours home blood pressure monitoring
Time frame: To baseline at 12 weeks
Mean arterial blood pressure assessed by 24-hours home blood pressure monitoring
Time frame: To baseline at 12 weeks
Change in physical activity: number of hour per day of physical activity
Time frame: To baseline at 12 weeks
pulse wave velocity
Time frame: To baseline at 12 weeks
Change in physical activity : Metabolic Equivalents (METS)
Time frame: To baseline at 12 weeks
Change in physical activity : Number of steps per day
Time frame: To baseline at 12 weeks
Change in sleep duration: Sleep to lying position duration ratio
Time frame: To baseline at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
Related trials for Hypertension, Resistant to Conventional Therapy
RecruitingPhase 4
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
Hypertension, Resistant to Conventional Therapy
Not yet recruiting
Expand Management of Blood Pressure With Renal Denervation in Patients Undergoing Staged PCI for Advanced Coronary Artery diseasE
Multivessel Coronary Artery Disease, Hypertension Resistant to Conventional Therapy
Recruiting
A Preventive, Multidisciplinary Primary Care Intervention Organized Around a Therapeutic Garden: Acceptability to Patients Suffering from Cardio-neurovascular Pathology and to Those Involved in the Action.
Vascular Disease, Cardiovascular
Active, not recruiting
RADIANCE Continued Access Protocol
Hypertension, Hypertension, Resistant to Conventional Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Louis Pépin, Pr MD PhD contact
Sandrine Bouzon contact
Jean-Louis Pépin, Pr MD PhD principal investigator
Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
5 sites in 3 countries: see every site and its status.
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.