Program to reduce blood pressure in sleep apnea patients with resistant hypertension
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
NA · AGIR à Dom · NCT02057783
This study is testing if a physical activity program combined with CPAP treatment can help people with sleep apnea and high blood pressure better control their blood pressure throughout the day.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | AGIR à Dom (other) |
| Locations | 5 sites (Québec and 4 other locations) |
| Trial ID | NCT02057783 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a physical activity program combined with CPAP treatment for patients suffering from obstructive sleep apnea syndrome (OSAS) and resistant hypertension. The hypothesis is that this combined approach will enhance 24-hour blood pressure control in these patients. Previous smaller studies have indicated that CPAP can significantly lower blood pressure during waking hours, and this study aims to build on that evidence with a larger sample size. Participants will be monitored for changes in blood pressure as they engage in the physical activity program alongside their CPAP treatment.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with obstructive sleep apnea and resistant hypertension who are not adequately controlled by three or more antihypertensive medications.
Not a fit: Patients with acute hypertension or contraindications to CPAP treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve blood pressure management in patients with resistant hypertension related to sleep apnea.
How similar studies have performed: Previous studies, including the HIPARCO study, have shown promising results in using CPAP for blood pressure reduction in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec and 4 other locations
- Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ) — Québec, Canada (RECRUITING)
- Hopital Universitaire de Grenoble — La Tronche, France (RECRUITING)
- Clinique Pasteur — Toulouse, France (RECRUITING)
- Hopitaux Universitaires de Genève — Geneva, Switzerland (WITHDRAWN)
- Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland (WITHDRAWN)
Study contacts
- Principal investigator: Jean-Louis Pépin, Pr MD PhD — Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
- Study coordinator: Jean-Louis Pépin, Pr MD PhD
- Email: JPepin@chu-grenoble.fr
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Resistant to Conventional Therapy, Sleep Apnea