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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Weijun Zhou, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01762436
First received: January 4, 2013
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Untreated Essential Hypertension
Drug: bisoprolol
Drug: atenolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study: Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension

Resource links provided by NLM:


Further study details as provided by Ruijin Hospital:

Primary Outcome Measures:
  • baroreflex sensitivity [ Time Frame: 4~8 weeks ] [ Designated as safety issue: No ]
    After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

  • central aortic pressure [ Time Frame: 4~8 weeks ] [ Designated as safety issue: No ]
    After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit


Secondary Outcome Measures:
  • heart rate variability [ Time Frame: 4~8 weeks ] [ Designated as safety issue: No ]
    After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

  • peripheral blood pressure [ Time Frame: 4-8 weeks ] [ Designated as safety issue: No ]
    After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4-8 weeks ] [ Designated as safety issue: Yes ]
    After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit


Enrollment: 109
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01762436

Locations
China, Shanghai
State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension and Department of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
  More Information

No publications provided by Ruijin Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weijun Zhou, Associate Profeesor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01762436     History of Changes
Other Study ID Numbers: Betablocker on CAP and BRS
Study First Received: January 4, 2013
Last Updated: January 7, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Atenolol
Bisoprolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014