Hypertension
Conditions
Keywords
Hypertension, Resistant Hypertension, Sleep apnea syndrome, Treatment
Brief summary
Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.
Detailed description
This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI \> 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP
Interventions
DEVICEactive CPAP
auto-PAP with pressure between 6 and 12 cm H2O or sham CPAP will be administered to randomized patients
DEVICEsham-CPAP
The sham-CPAP was the same equipment used for active CPAP (Respironics Remstar-Auto, Murraysville, PA) fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al. The differences between the two were undetectable except for the pressure generated in the facial mask in the sham-CPAP that was no greater than 1cm H2O.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of resistant hypertension * Apnea/hypopnea index \> 15
Exclusion criteria
* Cardiac surgery on last 3 months * Serious arrhythmias * Insulin dependent diabetes * Debilitating neurological disease * severe COPD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring | 8 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| aldosterone, renin, activated protein C | 8 weeks |
Countries
Brazil
Outcome results
None listed