An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Bisoprolol; Atenolol
Intervention description: Bisoprolol tablet will be administered orally at a dose of 5 milligram (mg) once daily in the morning for 12 weeks.; Atenolol tablet will be administered orally at a dose of 50 mg once daily in the morning for 12 weeks.
Intervention MeSH terms: Atenolol; Bisoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 209.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bisoprolol; Atenolol; Hypertension; Blood pressure

Summary:

      Antihypertensive drugs aim to reduce blood pressure (BP) either through decrease of the total
      peripheral resistance through vasodilatation at the level of arterioles (microcirculation) or
      by decreasing the cardiac output through reduction of the stroke volume or heart rate or
      both. On the other hand, all antihypertensive drugs might potentially decrease arterial
      stiffness passively with the reduction of the distending pressure or with the
      resynchronization of the reflected pressure wave. With theses potential mechanisms, it is
      also expected that these drugs might exert a favorable effect on pulse pressure amplification
      between central and peripheral arteries.

      However, there is solid evidence that the widely applied antihypertensive drugs have
      differential effect on brachial and central BP. Several reports in the past have confirmed
      the potential hypothesis that beta blockers decrease central BP less than the observed
      reduction at the level of the brachial artery. It has been hypothesized that deceleration of
      heart rate and the re synchronizing the reflected pressure wave earlier in the systolic phase
      seems to be the leading cause of non-favorable effect of beta blockers on central BP, these
      effects might be partially counterbalanced in beta blockers with high beta-1 selectivity
      resulting in less peripheral vasoconstriction properties.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An antihypertensive-naive subject or a subject who has not been taking the previously
             administered antihypertensive agent for at least 4 weeks prior to screening

          -  Subjects aged between 20 and 75 years, inclusive

          -  Subjects with systolic blood pressure (SBP) greater than or equal to 140 millimeter of
             mercury (mmHg) and less than 180 mmHg or diastolic blood pressure (DBP) greater than
             or equal to 90 mmHg and less than 110 mmHg

        Exclusion Criteria:

          -  Subjects with secondary hypertension

          -  Subjects with renal impairment (Creatinine greater than 150 micromoles/liter [mcmol/L]
             or Creatinine greater than 1.7 mg/deciliter [dL])

          -  Subjects with severe hypertension (Stage III) SBP greater than or equal to 180 mmHg or
             DBP greater than or equal to 110 mmHg

          -  Subjects with congestive heart failure, acute myocardial infarction, unstable angina

          -  Subjects with moderate bronchial asthma, chronic obstructive pulmonary disease

          -  Subjects with symptomatic bradycardia, radial artery injury, second degree or third
             degree atrioventricular (AV) block, atrial fibrillation, atrial flutter, left bundle
             branch block (LBBB)

          -  Subjects with a history of hypersensitivity to bisoprolol and atenolol products

          -  Pregnancy or breastfeeding women