Evaluation of the effect of the treatment with airway positive pressure device on blood pressure levels of hypertensive patients with sleep apnea syndrome.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-6mbrrk
• Date of registration: 26/01/2012
• Primary sponsor: Faculdade de Medicina - Universidade Federal do Rio de Janeiro - Rio de Janeiro, RJ, Brazil
• Public title: Evaluation of the effect of the treatment with airway positive pressure device on blood pressure levels of hypertensive patients with sleep apnea syndrome.
• Scientific title: Efficacy of continuous positive airway pressure on blood pressure control of resistant hypertensive patients with obstructive sleep apnea syndrome.
• Date of first enrolment: 01/07/2011
• Target sample size: 200
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-6mbrrk/
• Study design: Randomized, parallel, single-blinded, 2 arms, therapeutic clinical trial.

Countries of recruitment

Brazil

Contacts

• Name: Gil Salles
• Affiliation: Faculdade de Medicina - Universidade Federal do Rio de Janeiro

• Name: Gil Salles
• Affiliation: Faculdade de Medicina - Universidade Federal do Rio de Janeiro

Key inclusion & exclusion criteria

Inclusion criteria: Patients with resistant hypertension and moderate-severe obstructive sleep apnea syndrome
Exclusion criteria: Marked cognitive deficit, non-adherence to anti-hypertensive treatment

Age minimum: 18Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

I00-I99

Resistant Hypertension, Obstructive Sleep Apnea Syndrome
C08.618.085.852.850
G47.3
C14.907.489
I10

Intervention(s)

Use of continuous positive airway pressure (CPAP) device during sleep for 6 months in 100 patients (intervention group). Other 100 patients (control group) will keep their usual anti-hypertensive treatment unchanged.

Primary Outcome(s)

Clinic and ambulatory blood pressures.
Measure: clinic and ambulatory blood pressure monitoring
Expected outcome: reduction of blood pressures in treatment group (at least 5 mmHg).

Secondary Outcome(s)

Aortic arterial stiffness.
Measure: carotid-femoral pulse wave velocity.
Expected outcome: reduction of arterial stiffness in the intervention group.

Autonomic System Balance Measurements: heart rate variability during 24-hour Holter monitoring.
Expected outcome: improvement in heart rate variability in the intervention group.

Cardiorespiratory fitness.
Measure: maximun oxigen consumption in ergospirometry.
Expected outcome: improvement in cardiorespiratory fitness in the intervention group.

Hyperaldosteronism measurements: serum aldosterone concentration, plasma renin activity and 24-hour urinary aldosterone excretion.
Expected outcome: reduction of hyperaldosteronism in the intervention group.

Microalbuminuria.
Measure: 24-hour urinary albumin excretion.
Expected outcome: reduction of microalbuminuria in the intervention group.

Secondary ID(s)

01.08.0615.00

242/08

520101/2009-0

Source(s) of Monetary Support

FINEP - Financiadora de Estudos e Projetos - Rio de Janeiro, RJ, Brazil

CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brasilia, DF, Brazil

FAPERJ - Fundação Carlos Chagas Filho de Amparo a Pesquisa do Estado do Rio de Janeiro - Rio de Janeiro, RJ, Brazil

Secondary Sponsor(s)

Hospital Universitário Clementino Fraga Filho - Rio de Janeiro, RJ, Brazil