A Phase 2/3 interventional study of Amlodipine and metoprolol in Sleep Apnea Syndrome and Hypertension, sponsored by First Affiliated Hospital of Harbin Medical University. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-15.
Sponsored by First Affiliated Hospital of Harbin Medical University · Phase 2/3, Interventional, and Treatment
Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to 7% in middle aged individuals and increases with age. OSA has been identified as the most common secondary cause associated with resistant hypertension. There is evidence that compared with older patients, the risk of hypertension in OSA patients may be particularly pronounced in younger adult ones (less than 50 years).
Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. In addition, it has been found that hypoxia condition in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP. However, the selections of antihypertensive drugs remain yet not very clearly for hypertensive patients combined with OSA.
Obstructive sleep apnea (OSA) is a highly prevalent chronic sleep disorder that affects 3% to 7% in middle aged individuals and increases with age. It is considered an important independent contributing factor for the development of hypertension, diabetes and heart rhythm disorders. The prevalence of arterial hypertension has been reported to reach 50% of patients with OSA. OSA has been identified as the most common secondary cause associated with resistant hypertension. There is evidence that compared with older patients, the risk of hypertension in OSA patients may be particularly pronounced in younger adult ones (less than 50 years).
Traditionally, cardiovascular risk stratification in hypertensive patients was based on the average blood pressure (BP) measured in the clinic. Accumulated data has shown that target-organ damage is related not only to 24-h mean intra-arterial BP, but also to BP variability (BPV) in subjects with essential hypertension. Growing evidence demonstrated that BPV has considerable prognostic value for all-cause mortality and cardiovascular outcomes, independent of average BP. In addition, it has been found that hypoxia condition in pneumoconiosis patients was closely associated with exaggerated BPV in ambulatory BP. However, the selections of antihypertensive drugs remain yet not very clearly for hypertensive patients combined with OSA.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →First Affiliated Hospital of Harbin Medical University is the lead sponsor of 73 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
To observe the effects of amlodipine (5mg) on blood pressure variation after 12 weeks of treatment
Drug: Amlodipine
To observe the effects of metoprolol (47.5mg) on blood pressure variation after 12 weeks of treatment
Drug: metoprolol
Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.
Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.
24-hour Ambulatory Blood Pressure Monitoring
Time frame: up to 3 years
24-hour continuous ambulatory electrocardiography
Time frame: up to 3 years
Ultrasonic echocardiography
Time frame: up to 3 years
This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Harbin Medical University