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

NCT ID: NCT01762436

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-02-29

Brief Summary

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.

Conditions

Untreated Essential Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

bisoprolol

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

atenolol

Intervention Type: DRUG

Interventions

bisoprolol

Intervention Type: DRUG

atenolol

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weijun Zhou

Associate Profeesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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 Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 24039738 (View on PubMed)

Other Identifiers

Betablocker on CAP and BRS

Identifier Type: -

Identifier Source: org_study_id