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OpenTrials
Completed

NCT Number: NCT01762436

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

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.

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Key information

Conditions

Untreated Essential Hypertension

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bisoprolol

Drug

Atenolol

Drug

Primary outcomes

  1. baroreflex sensitivity

    Time frame: 4~8 weeks

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

  2. 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

  1. heart rate variability

    Time frame: 4~8 weeks

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

  2. peripheral blood pressure

    Time frame: 4-8 weeks

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

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

    Time frame: 4-8 weeks

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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 7, 2013
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.