Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term.
The purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.
We assess the prevalence of an apnea hypopnea index (AHI) > 5 in patients with refractory hypertension referred from a hypertension clinic. Patients with an AHI >15 are randomized to either continuing their usual pharmacological treatment alone or adding CPAP to their usual treatment, during a 3 month period.
The main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as assessed by ambulatory blood pressure monitoring, between both treatment arms. The secondary endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 CPAP | Active Comparator | Nasal continuous positive airway pressure |
|
| 2 | No Intervention | Pharmacological treatment alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cpap treatment during sleep | Device | CPAP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure . | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lourdes Lozano, MD | Hospital General Universitari Vall d'Hebron | Principal Investigator |
| Jose Luis Tovar, MD | Hospital General Universitari Vall d'Hebron | Study Chair |
| Gabriel Sampol, MD | Hospital General Universitari Vall d'Hebron | Study Chair |
| Odile Romero, MD | Hospital General Universitari Vall d'Hebron | Study Chair |
| Pilar Chacon, MD | Hospital General Universitari Vall d'Hebron | Study Chair |
| Jose Rios | Universitat Autonoma de Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servei de Pneumologia, Hosital general Universitari Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D012140 |
| Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |