A Randomized Controlled Study: Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ruijin Hospital
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- baroreflex sensitivity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
Arms & Interventions
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.
Intervention: bisoprolol (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.
Intervention: atenolol (Drug)
Outcomes
Primary Outcomes
baroreflex sensitivity
Time Frame: 4~8 weeks
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
After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit
Secondary Outcomes
- heart rate variability(4~8 weeks)
- peripheral blood pressure(4-8 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(4-8 weeks)
Investigators
Weijun Zhou
Associate Profeesor
Ruijin Hospital