Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension

A Randomized Controlled Study: Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension

β-blockers (BBs) with different pharmacological properties may have heterogeneous effects on sympathetic nervous activity (SNA) and central aortic pressure (CAP), which are independent cardiovascular factors for hypertension. Hence, we analyzed the effects of bisoprolol and atenolol on SNA and CAP in hypertensive patients.

Study Overview

• Status: Completed
• Conditions: Untreated Essential Hypertension
• Intervention / Treatment: Drug: bisoprolol; Drug: atenolol

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension and Department of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 25~65 years old
• untreated essential hypertension
• SBP 140-160mmHg & DBP 90-100mmHg
• Sinus rhythm
• Resting heart rate >70bpm
• Can give written informed consent

Exclusion Criteria:

• Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade(AVBⅡ-Ⅲ) without pacemaker
• Bradyarrhythmia/ hypotensive
• Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III - IV)
• Uncontrolled diabetes mellitus (DM)
• Bronchial asthma
• Gastro-intestinal ulcer or skin ulcer
• Liver dysfunction/ renal impairment
• Treated with CCB (Calcium antagonists) ( except amlodipine) or other beta blocker.
• Glaucoma
• Known allergic/ intolerance to beta blocker
• Pregnant or lactating women
• Participation in another clinical study within the last 3 months
• Legal incapacity or limited legal capacity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bisoprolol; initially received 5 mg of bisoprolol (Concor®, Merck Serono, Darmstadt, Germany) once daily. The heart rate was assessed every two weeks. If the RHR was ≤65 bpm, a 2-week maintenance treatment was added during the final visit. If the target RHR was not achieved, the dose was changed as recommended in the study protocol. The maximal dose was 10 mg Qd for bisoprolol. The longest treatment period was 8 weeks. If the patient's RHR did not reach below 65 bpm at week 6, the treatment was ended at week 8.	Drug: bisoprolol
Active Comparator: atenolol; initially received 50 mg atenolol (Beijing Double-Crane Pharmaceutical Co., Ltd, Beijing, China) once daily. The heart rate was assessed every two weeks. If the RHR was ≤65 bpm, a 2-week maintenance treatment was added during the final visit. If the target RHR was not achieved, the dose was changed as recommended in the study protocol. The maximal dose was 100 mg Qd for atenolol. The longest treatment period was 8 weeks. If the patient's RHR did not reach below 65 bpm at week 6, the treatment was ended at week 8.	Drug: atenolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
baroreflex sensitivity	After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit	4~8 weeks
central aortic pressure	After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit	4~8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate variability	After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit	4~8 weeks
peripheral blood pressure	After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit	4-8 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit	4-8 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Publications and helpful links

General Publications

• Zhou WJ, Wang RY, Li Y, Chen DR, Chen EZ, Zhu DL, Gao PJ. A randomized controlled study on the effects of bisoprolol and atenolol on sympathetic nervous activity and central aortic pressure in patients with essential hypertension. PLoS One. 2013 Sep 10;8(9):e72102. doi: 10.1371/journal.pone.0072102. eCollection 2013.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: January 4, 2013
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 7, 2013

Study Record Updates

• Last Update Posted (Estimate): January 8, 2013
• Last Update Submitted That Met QC Criteria: January 7, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Bisoprolol; Atenolol
• Other Study ID Numbers: Betablocker on CAP and BRS