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Completed

NCT Number: NCT00881985

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong, 852, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure

Device

Use CPAP whenever sleep

Other names: CPAP

Primary outcomes

  1. mean systolic blood pressure

    Time frame: 8 weeks

Secondary outcomes

  1. mean arterial blood pressure

    Time frame: 8 weeks

  2. mean diastolic blood pressure

    Time frame: 8 weeks

  3. high sensitivity C-reactive protein

    Time frame: 8 weeks

  4. cardiac injury marker

    Time frame: 8 weeks

  5. oxidative stress marker

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2009
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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