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

Efficacy of continuous positive airway pressure on blood pressure control of resistant hypertensive patients with obstructive sleep apnea syndrome.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6mbrrk
Enrollment
Unknown
Registered
2012-01-26
Start date
2011-07-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resistant Hypertension, Obstructive Sleep Apnea Syndrome

Interventions

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 trea
procedure/surgery
SP1.011.122

Sponsors

Faculdade de Medicina - Universidade Federal do Rio de Janeiro
Lead Sponsor
Hospital Universitário Clementino Fraga Filho
Collaborator

Eligibility

Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with resistant hypertension and moderate-severe obstructive sleep apnea syndrome

Exclusion criteria

Exclusion criteria: Marked cognitive deficit, non-adherence to anti-hypertensive treatment

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Microalbuminuria. Measure: 24-hour urinary albumin excretion. Expected outcome: reduction of microalbuminuria 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. ;Aortic arterial stiffness. Measure: carotid-femoral pulse wave velocity. Expected outcome: reduction of arterial stiffness in the intervention group.;Cardiorespiratory fitness. Measure: maximun oxigen consumption in ergospirometry. Expected outcome: improvement in cardiorespiratory fitness 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.—

Countries

Brazil

Contacts

Public ContactGil Salles

Faculdade de Medicina - Universidade Federal do Rio de Janeiro

gilsalles@hucff.ufrj.br21-25622514

Outcome results

None listed

Source: REBEC (via WHO ICTRP)