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

Shanghai Jiao Tong University

Status and phase: Completed; Phase 4

Conditions: Untreated Essential Hypertension

Treatments: Drug: bisoprolol; Drug: atenolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01762436

Betablocker on CAP and BRS

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 2 patient groups

bisoprolol

Experimental group

Description:

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.

Treatment:

Drug: bisoprolol

atenolol

Active Comparator group

Description:

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.

Treatment:

Drug: atenolol