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

Study Overview
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Brief Summary
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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.

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

Conditions
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Untreated Essential Hypertension

Intervention / Treatment
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* Drug: bisoprolol
* Drug: atenolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bisoprolol<br>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<br> <br> |
| Active Comparator: atenolol<br>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<br> <br> |

What is the study measuring?
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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 |