Clinical trial NCT00459914: Sleep Apnea and Refractory Hypertension: Prevalence and Effect of CPAP Treatment
Official title: Sleep Apnea in Patients With Refractory Hypertension: Study of the Prevalence and the Effect of CPAP Treatment on Blood Pressure Control, Endothelial Dysfunction and Angiogenesis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Sleep Apnea
Keywords: sleep apnea
refractory hypertension
continuous positive airway pressure
Lead sponsor: Fundacio Catalana de Pneumologia
Sponsor class: OTHER
First posted: 2007-04-13
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Patients referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmHg despite the recommended doses of at least 3 drugs, including a diuretic.

Exclusion Criteria:

* Causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.

Primary outcomes:
measure: Effect of 3 months of CPAP versus conventional pharmacological treatment on the mean 24 h systolic and diastolic blood pressure .
timeFrame: 3 months
Secondary outcomes:
measure: Effect of CPAP versus conventional pharmacological treatment on inflammatory, endothelial function and angiogenesis serum biomarkers
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Servei de Pneumologia, Hosital general Universitari Vall d'Hebron
Study officials:
affiliation: Hospital General Universitari Vall d'Hebron
name: Lourdes Lozano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Universitari Vall d'Hebron
name: Jose Luis Tovar, MD
role: STUDY_CHAIR
affiliation: Hospital General Universitari Vall d'Hebron
name: Gabriel Sampol, MD
role: STUDY_CHAIR
affiliation: Hospital General Universitari Vall d'Hebron
name: Odile Romero, MD
role: STUDY_CHAIR
affiliation: Hospital General Universitari Vall d'Hebron
name: Pilar Chacon, MD
role: STUDY_CHAIR
affiliation: Universitat Autonoma de Barcelona
name: Jose Rios
role: STUDY_CHAIR
References: