Clinical trial NCT01251146: A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension
Official title: Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Bisoprolol
Atenolol
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Co., Ltd., China
First posted: 2010-12-01
Enrollment: 177
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous system's (SNS) activity in subjects with essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Subjects aged between 25-65 years
* Subjects with essential hypertension (EH)
* Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
* Subjects with normal sinus rhythm
* Subjects with resting heart rate (RHR) greater than 70 bpm
* Subjects who give written informed consent

Exclusion Criteria:

* Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
* Subjects with bradyarrhythmia/hypotension
* Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association \[NYHA\] Class III - IV)
* Subjects with uncontrolled diabetes mellitus (DM)
* Subjects with bronchial asthma
* Subjects with gastro-intestinal ulcer or skin ulcer
* Subjects with liver dysfunction/renal impairment
* Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
* Subjects with glaucoma
* Subjects with known allergic/intolerance to beta-blocker
* Pregnant or lactating women
* Subjects who had participated in another clinical study within the last 3 months
* Subjects who have legal incapacity or limited legal capacity

Primary outcomes:
measure: Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal
timeFrame: Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)
measure: Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up
timeFrame: Baseline and end of follow-up (Week 4 or Week 6 or Week 8)
Secondary outcomes:
measure: Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up
timeFrame: Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
measure: Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up
timeFrame: Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
measure: Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment
timeFrame: Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)
measure: Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6
timeFrame: Attainment of heart rate goal (Week 2 or Week 4 or Week 6)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
measure: Number of Participants Compliant With Study Treatment
timeFrame: Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shi Jingshan Hospital
city: Shanghai
country: China
facility: Shanghai Institute of Hypertension
Study officials:
affiliation: Shanghai Institute of Hypertension
name: Gao Pingjin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: