Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome

Hypertension Clinical Trial

Official title:

The Study Was Approved by the Ethics Committee of Our Institution, Which is Accredited by the Office of Human Research Protection as an Institutional Review Board

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02408172
• Other study ID #: OSA-HT-1
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 12, 2015
• Last updated: February 13, 2017
• Start date: October 2013
• Est. completion date: December 2017

Study information

• Verified date: October 2014
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yue Li, PHD
• Phone: 86-451-85555673
• Email: ly99ly[@]vip.163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men aged between 18 and 75 included years old, and

• Postmenopausal women who are no more than 75 years older.

• Patients with essential mild to moderate uncomplicated hypertension (DBP<110mmHg and SBP<180mmHg measured with a validated automatic device in sitting position) after initiation or intensification of appropriate healthy lifestyle modification,

• Without antihypertensive treatment in 2 weeks.

Exclusion Criteria:

• History of cerebrovascular disease: ischemic stroke, cerebral haemorrhage and TIA.

• History of cardiovascular disease:unstable angina, myocardial infarction, coronary revascularization and congestive heart failure.

• History of renal impairment.

• History of Type I diabetes mellitus or Type II diabetes uncontrolled.

• History of liver impairment.

• History of alcoholism or drug abuse.

• Known symptomatic orthostatic hypotension.

• Contra-indications to treatment with investigate products.

Related Conditions & MeSH terms

• Apnea
• Hypertension
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Intervention

Drug:
• Amlodipine
Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.
• metoprolol
Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.

Locations

Country	Name	City	State
China	Portable polysomnography	Suzhou	Jiangsu
Hungary	Twenty-four-hour ambulatory BP monitoring	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Countries where clinical trial is conducted

China,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Ambulatory Blood Pressure Monitoring		up to 3 years
Secondary	24-hour continuous ambulatory electrocardiography		up to 3 years
Secondary	Ultrasonic echocardiography		up to 3 years