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

Phase 4

Completed

• Conditions: Untreated Essential Hypertension
• Interventions: Drug: bisoprolol; Drug: atenolol

• Registration Number: NCT01762436
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-01
• Study First Submitted: 2013-01-04
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Last Update Submitted: 2013-01-07
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bisoprolol	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.
atenolol	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
heart rate variability	4~8 weeks	After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
peripheral blood pressure	4-8 weeks	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	4-8 weeks	After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

Trial Locations

Locations (1)

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