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

NCT01762436 | Completed Phase 4

• 1 other identifier: Betablocker on CAP and BRS
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Untreated Essential Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

bisoprolol

EXPERIMENTAL

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

atenolol

ACTIVE COMPARATOR

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

Interventions

bisoprolol DRUG

bisoprolol

atenolol DRUG

atenolol

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~65 years old
• untreated essential hypertension
• SBP 140-160mmHg \& DBP 90-100mmHg
• Sinus rhythm
• Resting heart rate \>70bpm
• Can give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension and Department of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (1)

• Zhou WJ, Wang RY, Li Y, Chen DR, Chen EZ, Zhu DL, Gao PJ. A randomized controlled study on the effects of bisoprolol and atenolol on sympathetic nervous activity and central aortic pressure in patients with essential hypertension. PLoS One. 2013 Sep 10;8(9):e72102. doi: 10.1371/journal.pone.0072102. eCollection 2013.

  PMID: 24039738 DERIVED

MeSH Terms

Interventions

Bisoprolol; Atenolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profeesor

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: January 7, 2013
• Study Start: November 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01

Locations

CN (1)