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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02408172
• Date of registration: 12/03/2015
• Prospective Registration: No
• Primary sponsor: First Affiliated Hospital of Harbin Medical University
• Public title: Effects of Metoprolol and Amlodipine on Cardiac Remodeling, Arrhythmias and Blood Pressure Variation in Hypertensive Patients With Sleep Apnea Syndrome
• Scientific 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
• Date of first enrolment: October 2013
• Target sample size: 20
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02408172
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 2/Phase 3

Countries of recruitment

China, Hungary

Contacts

• Name: Yue Li, PHD

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Sleep Apnea Syndrome

Intervention(s)

Drug: metoprolol

Drug: Amlodipine

Primary Outcome(s)

24-hour Ambulatory Blood Pressure Monitoring [Time Frame: up to 3 years]

Secondary Outcome(s)

Ultrasonic echocardiography [Time Frame: up to 3 years]

24-hour continuous ambulatory electrocardiography [Time Frame: up to 3 years]

Secondary ID(s)

OSA-HT-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors