- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00202527
Spanish Cohort for the Study of the Effect of CPAP in Hypertension (CEPECTA)
Efficacy of the Treatment With Nasal Positive Continuous Airway Pressure to Reduce the Arterial Blood Pressure in Patients With Apneas-Hypopneas During the Sleep and Systemic Hypertension
AIMS:To know the effects of the treatment with nasal positive continuous airway pressure (CPAP) on systemic blood pressure and the expression of biological mediators, in systemic hypertension of recent diagnostic, whose have an apnea-hypopnea index > 15.
METHODOLOGY: DESIGN: Prospective, multicenter, randomized study, of parallel groups and controlled with placebo, in patients diagnosed of systemic hypertension (SH) with an apnea-hypopnea index, by conventional polysomnography > 15. A total of 340 patients with recently diagnosed of SH and without any pharmacological treatment will be studied. All patients will be randomized to receive, alternatively, CPAP treatment with optimal pressure titled with a proved system, or Sham-CPAP for 12 weeks.
MEASUREMENTS: A) Conventional polysomnography at baseline: B) Clinic: sleepiness (ATS, Basic Nordic Sleep Questionnaire and Epworth), quality of life (EuroQol); C) 24 hour blood pressure monitoring; D) Expression of biological mediators in blood: general determinations, endothelial, inflammatory, lipid, renin-angiotensin-aldosterone and adrenergic mediators.
ANALYSIS. Baseline measurements of all the variables will be compared with the situation at six and twelve weeks. We will use the chi square test and the Fisher´s exact test (categorical variables), the t test for continous variables and repeated measures ANCOVA for the primary objective. The analyses will be done under the criterion of intention to treat and for protocol. The variables will be controlled by the compliance with the CPAP..
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: JOAQUIN DURAN-CANTOLLA, MD
- Phone Number: 34 945 007308
- Email: joaquin.duran@wanadoo.es
Study Locations
-
-
Alava
-
Vitoria, Alava, Spain, 01009
- Recruiting
- Unit of Research. Hospital Txagorritxu
-
Contact:
- JOAQUIN DURAN-CANTOLLA, MD
- Phone Number: 34 945 007308
- Email: joaquin.duran@wanadoo.es
-
Principal Investigator:
- JOAQUIN DURAN-CANTOLLA, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients, both sexes from 18 to 75 years old, with clinical suspected of OSAH defined by an apnea-hypopnea index > 15 and having a recent diagnosis of hypertension which have not received any pharmacological treatment for hypertension.
Exclusion Criteria:
Inclusion Criteria:
- Patients with clinical suspected of OSAH defined by an apnea-hypopnea index > 15 and having a recent diagnosis of hypertension which have not received any pharmacological treatment for hypertension.
Exclusion Criteria:
- Severe excessive daytime sleepiness; professional drivers; pregnant women; alcohol consumption more than 100 gr. Ethanol per day; sedative medication; psychiatric illness; malignant or complicated hypertension; renal insufficiency; severe chronically ilness or malignant ilness; severe craniomandibular disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Effect of CPAP in 24 hours blood pressure monitoring
|
effect of CPAP y quality of life and clinical aspects
|
Secondary Outcome Measures
Outcome Measure |
---|
effect of CPAP in biologic mediators
|
Collaborators and Investigators
Investigators
- Principal Investigator: JOAQUIN DURAN-CANTOLLA, MD, Sociedad Española de Cirugía Torácica
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI041110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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