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An Active-controlled, Clinical Trial to Assess Central Haemodynamic Effects of Bisoprolol in Hypertensive Patients

2014-08-27 03:15:29 | BioPortfolio

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 antihypertensives drugs might potentially decrease arterial stiffness passively with the reduction of the distending pressure or with the re synchronisation of the reflected pressure wave. With theses potential mechanisms, it is also expected that these drugs might exert a favourable effect on pulse pressure amplification between central and peripheral arteries.

However, there is a solid evidence that the widely applied antihypertensive drugs has differential effect on brachial and central BP. Several reports in the past has 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 hypothesised 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-favourable 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.

The primary and secondary hypothesis for this prospective, multi-center, randomised, open label, active-controlled clinical trial are as follows:

Primary hypothesis:

- Treatment with bisoprolol for 12 weeks significantly reduces the aortic pulse pressure as compared to atenolol group

Secondary hypothesis:

- Treatment with bisoprolol for 12 weeks significantly reduces the aortic BP as compared to atenolol group

- The efficacy of bisoprolol in reducing peripheral BP is comparable with that of atenolol

Description

Central pulse pressure is a better predictor of left ventricular mass and carotid intima thickness, and the conventional peripheral BP does not seem to be an accurate reflection of central arterial BP. The pulse pressure amplification between peripheral and central arteries reflects the left ventricular afterload, subendothelial viability, and the intensity of cyclic stress imposed to the renal and cerebral micro- and macro vessels. As central haemodynamic parameters are independently associated with organ damage and are closely related to important cardiovascular outcome, it is suggested that the new clinical trials on antihypertensive drug treatment should compare simultaneously the chronic effEct of drugs on both peripheral and central BP.

OBJECTIVES

Primary objective:

- To evaluate the effect of bisoprolol versus atenolol, on central haemodynamics as determined by aortic pulse pressure in subjects with hypertension

Secondary objectives:

- To evaluate the effect of bisoprolol versus atenolol, on central haemodynamics as determined by aortic BP in subjects with hypertension

- To evaluate the effect of bisoprolol versus atenolol, on large arterial stiffness as determined by Aortic Augmentation Index (AI) and the aortic pulse wave velocity (aPWV) in subjects with hypertension

- To evaluate the effect of bisoprolol versus atenolol, on central haemodynamics as determined by aortic pulse pressure at interim visit (week 4)

- To evaluate the effect of bisoprolol versus atenolol, on metabolism as determined by lipid profile and serum glucose

- To evaluate the effect of bisoprolol versus atenolol, on peripheral BP as determined by brachial BP in subjects with hypertension

- To evaluate the safety and tolerability of bisoprolol versus atenolol, in subjects with hypertension

The present study will be approximately of 14 weeks duration comprising of 2 weeks screening, followed by a 3 month treatment period and a 2 weeks post study follow up contact conducted via telephone to monitor additional serious adverse experiences.

There will be 4 scheduled visits (at Day -14, 1,4 week and 3 month). After screening period in which eligibility criteria were confirmed, subjects with hypertension will be randomised in a 1:1 ratio to receive treatment with either bisoprolol or atenolol. Haemodynamic and biochemical measurements will be made at baseline, and again at the end of the each treatment phase.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hypertension

Intervention

Bisoprolol, Atenolol

Location

Severance Hosptial, 250, Seongsanno, Seodaemungu
Seoul
Korea, Republic of

Status

Recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:29-0400

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