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

Primary Purpose

Untreated Essential Hypertension

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

bisoprolol

atenolol

About this trial

This is an interventional treatment trial for Untreated Essential Hypertension

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bisoprolol

atenolol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

baroreflex sensitivity

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

central aortic pressure

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

Secondary Outcome Measures

heart rate variability

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

peripheral blood pressure

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

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

Full Information

NCT ID

NCT01762436

First Posted

January 4, 2013

Last Updated

January 7, 2013

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01762436

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Untreated Essential Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

109 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bisoprolol

Arm Type

Experimental

Arm Description

Arm Title

atenolol

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

bisoprolol

Intervention Type

Drug

Intervention Name(s)

atenolol

Primary Outcome Measure Information:

Title

baroreflex sensitivity

Description

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

Time Frame

4~8 weeks

Title

central aortic pressure

Description

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

Time Frame

4~8 weeks

Secondary Outcome Measure Information:

Title

heart rate variability

Description

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

Time Frame

4~8 weeks

Title

peripheral blood pressure

Description

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

Time Frame

4-8 weeks

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Description

After 2-week maintenance treatment when the RHR was ≤65 bpm or at 8-week final visit

Time Frame

4-8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

24039738

Citation

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.

Results Reference

derived

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

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