A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension

Condition(s) targeted: Hypertension

Intervention: Bisoprolol (Drug); Atenolol (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Gao Pingjin, Prof., Principal Investigator, Affiliation: Shanghai Institute of Hypertension

Overall contact:
Medical Advisor, Phone: +86 (10) 5907 2458

This is a phase IV, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous system's (SNS) activity in subjects with essential hypertension. A total of 192 subjects are planned to be enrolled in various centers in China.

Official title: Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Patients With Essential Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes of Baroreflex sensitivity (BRS)

Secondary outcome:

Changes of heart rate variability parameters

Serum concentration in plasma concentration of epinephrine (E) , norepinephrine(NE) , angiotensin-2 II(Ang II) , aldosterone (ALD) and renin activity ( RA) before and after RHR<65bpm in 2 groups

Dosage and duration in days of attaining RHR<65bpm after bisoprolol and atenolol treatment

Number of participants with adverse events (AE) and serious adverse events (SAE)

Participants compliance for bisoprolol and atenolol treatment after RHR<65bpm

Minimum age: 25 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects aged between 25-65 years old

- Subjects with essential hypertension (EH)

- Systolic blood pressure (SBP) 140-160mm Hg & diastolic blood pressure (DBP) 90-100mm

Hg

- Subjects with normal sinus rhythm

- Resting heart rate (RHR)>70bpm

- Subjects who can give written informed consent

Exclusion Criteria:

- Subjects having atrial fibrillation (AF)/ sick sinus syndrome (SSS)/ atrioventricular

block 2-3 grade (AVB II-III) without pacemaker

- bradyarrhythmia/ hypotension

- Subjects having unstable angina pectoris (UAP)/ acute myocardial infarction (AMI)/

heart failure (HF) (New York Heart Association (NYHA) class III - IV)

- Subjects with uncontrolled diabetes mellitus (DM)

- Subjects with bronchial asthma

- Subjects with gastro-intestinal ulcer or skin ulcer

- Subjects with liver dysfunction/ renal impairment

- Subjects treated with CCB (Calcium antagonists, except amlodipine) or beta blockers.

- Subjects with glaucoma

- Subjects with known allergic/intolerance to beta blocker

- Pregnant or lactating women

- Subjects who have participated in another clinical study within the last 3 months

- Legal incapacity or limited legal capacity

Medical Advisor, Phone: +86 (10) 5907 2458

Beijing Shi Jingshan Hospital, Beijing, China; Recruiting
Mingsheng Wang
Minsheng Wang, Principal Investigator

Shanghai Institute of Hypertension, Shanghai, China; Recruiting
Gao Pingjin, Prof.
Gao Pingjin, Prof., Principal Investigator

Starting date: December 2010
Last updated: June 15, 2011