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

Phase 4

Completed

Conditions: Hypertension

Interventions: Drug: Bisoprolol
Drug: Atenolol

Registration Number: NCT01251146

Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 177

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bisoprolol	Bisoprolol	-
Atenolol	Atenolol	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal	Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)	Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).
Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up	Baseline and end of follow-up (Week 4 or Week 6 or Week 8)	Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.

Secondary Outcome Measures

Name	Time	Method
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	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)	Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment	Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)	Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
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	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)	Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6	Attainment of heart rate goal (Week 2 or Week 4 or Week 6)	Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)	AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition
Number of Participants Compliant With Study Treatment	Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)	Participants compliant with study treatment were the participants who have completed the study treatment regimen.