Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Resistant Hypertension

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Resistant Hypertension
• Interventions: Device: continuous positive airway pressure

• Registration Number: NCT00881985
• Lead Sponsor: The University of Hong Kong

Brief Summary

The objectives of this study are to investigate the effect of continuous positive airway pressure (CPAP) treatment on blood pressure control and vascular inflammation in subjects with resistant hypertension and moderate obstructive sleep apnea (OSA).

Detailed Description

Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. Resistant hypertension is defined in order to identify patients who are at risk of having secondary causes of hypertension, and who may benefit from specific diagnostic and therapeutic applications. Despite the fact that OSA is listed as one of the causes of resistant HT , paucity of works has demonstrated the magnitude of problems of untreated OSA in subjects with resistant HT. There is so far two study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though both studies were flawed by not including the control group, no randomization and limited sample size. We aim at conducting a randomized controlled study to explore the beneficial effect of CPAP treatment in subjects with OSA and resistant hypertension.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-15
• Study First Posted: 2009-04-16
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

• Age 18 - 65
• known hypertension on ≧ 3 anti-hypertensive drugs
• Apnea-hypopnea index ≧15
• able to give informed written consent

Exclusion Criteria

• moderate renal impairment (glomerular filtration rate <30 mL/min/m2 )
• endocrine/renal/cardiac causes of secondary HT
• congestive heart failure and clinically fluid overloaded
• On drugs that elevates BP e.g. NSAID, steroid
• Non-compliance to anti-hypertensive medications
• Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months
• Active inflammatory/infective conditions e.g. rheumatoid arthritis
• Excessive sleepiness that can be risky e.g. occupational driver, machine operator
• Modification/changes of anti-hypertensive regimen within 8 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous positive airway pressure	continuous positive airway pressure	-

Primary Outcome Measures

Name	Time	Method
mean systolic blood pressure	8 weeks

Secondary Outcome Measures

Name	Time	Method
mean arterial blood pressure	8 weeks
mean diastolic blood pressure	8 weeks
high sensitivity C-reactive protein	8 weeks
cardiac injury marker	8 weeks
oxidative stress marker	8 weeks

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, China