Spanish Cohort for the Study of the Effect of CPAP in Hypertension (CEPECTA)
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|ClinicalTrials.gov Identifier: NCT00202527|
Recruitment Status : Unknown
Verified September 2005 by Sociedad Española de Neumología y Cirugía Torácica.
Recruitment status was: Recruiting
First Posted : September 20, 2005
Last Update Posted : December 23, 2005
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..
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Hypertension||Device: Nasal continuos positive airway pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||January 2005|
|Study Completion Date :||September 2005|
- Effect of CPAP in 24 hours blood pressure monitoring
- effect of CPAP y quality of life and clinical aspects
- effect of CPAP in biologic mediators
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202527
|Contact: JOAQUIN DURAN-CANTOLLA, MD||34 945 email@example.com|
|Unit of Research. Hospital Txagorritxu||Recruiting|
|Vitoria, Alava, Spain, 01009|
|Contact: JOAQUIN DURAN-CANTOLLA, MD 34 945 007308 firstname.lastname@example.org|
|Principal Investigator: JOAQUIN DURAN-CANTOLLA, MD|
|Principal Investigator:||JOAQUIN DURAN-CANTOLLA, MD||Sociedad Española de Cirugía Torácica|