A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension
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Purpose
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
| Condition |
|---|
|
Obstructive Sleep Apnea Resistant Hypertension |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | A Cross-sectional Study of the Occurrence and Effect of Obstructive Sleep Apnea in Subjects With Resistant Hypertension |
Blood test for glucose, lipid, vascular and metabolic markers
| Estimated Enrollment: | 96 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
resistant hypertension subjects
subjects with resistant hypertension
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Consecutive sampling of subjects who attend Hypertension clinic , Department of Medicine, Queen Mary Hospital, and who fulfill the inclusion criteria.
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
Contacts and Locations| 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 | |
| Department of Medicine, The University of Hong Kong, Queen Mary Hospital | Recruiting |
| Hong Kong, Hong Kong, 852 | |
| Contact: Sau Man Mary Ip, MD 852-28554455 msmip@hkucc.hku.hk | |
| Principal Investigator: | Sau Man Mary Ip, MD | Department of Medicine, The University of Hong Kong |
More Information
Publications:
| Responsible Party: | Professor Ip, Sau Man Mary, Department of Medicine, The University of Hong Kong, Queen Mary Hospital |
| ClinicalTrials.gov Identifier: | NCT00843583 History of Changes |
| Other Study ID Numbers: | NCT00808421 |
| Study First Received: | February 12, 2009 |
| Last Updated: | July 27, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by The University of Hong Kong:
|
prevalence obstructive sleep apnea resistant hypertension |
Additional relevant MeSH terms:
|
Apnea Hypertension Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Vascular Diseases Cardiovascular Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013