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

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ClinicalTrials.gov Identifier: NCT00881985
Recruitment Status : Recruiting
First Posted : April 16, 2009
Last Update Posted : May 22, 2018
Sponsor:
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Resistant Hypertension Obstructive Sleep Apnea Device: continuous positive airway pressure Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Continuous Positive Airway Pressure for Treatment of Obstructive Sleep Apnea on Drug-resistant Hypertension : A Randomized Controlled Trial
Study Start Date : March 2009
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: continuous positive airway pressure Device: continuous positive airway pressure
Use CPAP whenever sleep
Other Name: CPAP
No Intervention: observation



Primary Outcome Measures :
  1. mean systolic blood pressure [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881985


Contacts
Contact: Mary SM Ip, MD 852-28554455 msmip@hkucc.hku.hk
Contact: Macy MS Lui, MRCP 852-28553312 macylui@graduate.hku.hk

Locations
China
Queen Mary Hospital Recruiting
Hong Kong, China, 852
Contact: Mary SM Ip, MD    852-28554455    msmip@hkucc.hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Mary SM Ip, MD The University of Hong Kong

Publications:

Responsible Party: Professor Ip Sau Man Mary, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00881985     History of Changes
Other Study ID Numbers: UW 09-051
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

Keywords provided by The University of Hong Kong:
obstructive sleep apnea
resistant hypertension
refractory hypertension
continuous positive airway pressure
blood pressure control

Additional relevant MeSH terms:
Hypertension
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases