A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00843583
First received: February 12, 2009
Last updated: July 27, 2010
Last verified: July 2010

February 12, 2009
July 27, 2010
February 2009
February 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00843583 on ClinicalTrials.gov Archive Site
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A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension
A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension

This study aims to investigate the prevalence of obstructive sleep apnea (OSA) in subjects with resistant hypertension and to evaluate the relationship between parameters of OSA severity and blood pressure control

Obstructive sleep apnea (OSA) is characterized by intermittent upper airway collapse during sleep, which results in hypoxia, arousals and surge in sympathetic activity. There is robust evidence to support a contributing role of OSA in hypertension (HT). The Sleep Heart Health Study (1), which recruited more than 6000 subjects having polysomnogram at home, found an independent association between OSA and HT. The adjusted odds ratio was 1.37 for subjects with and apnea-hypopnea index >= 30/hour compared to those without apnea. The Wisconsin Sleep Cohort Study , which provided prospective longitudinal follow-up for OSA subjects over 4 years, have shown dose dependency of the severity of OSA and the risk of development of HT. Current available data suggests that in hypertensive patients with severe OSA, there is a BP drop of about 10mmHg with CPAP treatment (2-5). The blood pressure (BP) lowering effect of CPAP treatment in the group with mild asymptomatic OSA is less consolidated.

The relationship between BP and risk of cardiovascular events is continuous, consistent, and independent of other risk factors. A strict blood pressure control is imperative in subjects with diabetes mellitus or renal impairment. Resistant hypertension is defined as blood pressure that remains above goal in spite of concurrent use of 3 antihypertensive agents of different classes. (6) 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 (6), paucity of works has demonstrated the scale of problems of untreated OSA in subjects with resistant HT. (7-9) There is so far one study demonstrating the beneficial effect of CPAP treatment in subjects with resistant HT, though no randomization was implemented and the sample size was limited (n=11). (10) We aim at conducting a cross-sectional study to explore the situation which would guide further clinical trial.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Retention:   Samples Without DNA
Description:

Blood test for glucose, lipid, vascular and metabolic markers

Non-Probability Sample

Consecutive sampling of subjects who attend Hypertension clinic , Department of Medicine, Queen Mary Hospital, and who fulfill the inclusion criteria.

  • Obstructive Sleep Apnea
  • Resistant Hypertension
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resistant hypertension subjects
subjects with resistant hypertension

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
Not Provided
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≧ 3 anti-HT drugs
  • age 18-65
  • mentally fit for signing an 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 elevate BP e.g. alcohol, NSAID, steroid
Both
18 Years to 65 Years
No
Contact: Sau Man Mary Ip, MD 852-28554455 msmip@hkucc.hku.hk
Contact: Mei Sze Macy Lui, MRCP 852-28553312 macylui@graduate.hku.hk
Hong Kong
 
NCT00843583
NCT00808421
No
Professor Ip, Sau Man Mary, Department of Medicine, The University of Hong Kong, Queen Mary Hospital
The University of Hong Kong
Not Provided
Principal Investigator: Sau Man Mary Ip, MD Department of Medicine, The University of Hong Kong
The University of Hong Kong
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP