Track topics on Twitter Track topics that are important to you
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:
- Treatment with bisoprolol for 12 weeks significantly reduces the aortic pulse pressure as compared to atenolol group
- 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
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.
- To evaluate the effect of bisoprolol versus atenolol, on central haemodynamics as determined by aortic pulse pressure in subjects with hypertension
- 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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Severance Hosptial, 250, Seongsanno, Seodaemungu
Korea, Republic of
Published on BioPortfolio: 2014-08-27T03:15:29-0400
This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose combination (FDC) of bisoprolol and amlodipine in hypertensive subjects.
A study to compare the effects of Diovan or Atenolol taken for 12 weeks on platelet function of patients who have mild to moderately severe hypertension
The b.p.m study will be performed to gain the insight in the courses of illness and therapy in subjects, suffering from hypertension and that have elevated heart rate. This study will show...
The researchers hypothesize that the impact of increasing systemic exposure to atenolol leads to increased risk for adverse metabolic effects from atenolol therapy in hypertension. This wi...
The purpose of this study is to determine the effects on exercise capacity of nebivolol compared to atenolol in hypertensive patients.
Fixed combinations of two or three drugs are being frequently used in cardiovascular diseases. This approach markedly increases adherence of the patients to prolonged therapy and thus leads to better ...
Bisoprolol and metoprolol are moderately lipophilic, beta(1)-selective betablockers reported to cause adverse effects in the central nervous system (CNS), such as sleep disturbance, suggesting that bo...
To investigate the effects of atenolol in inflammatory mediator and oxidative stress in a myocardial injury by intestinal ischemia/reperfusion in rat model.
Kinetic resolution of (R,S)-atenolol is a faster strategy to produce (S)-atenolol. Since this racemate is a less soluble compound, resolution of its ester offers high concentrations in the process. A ...
In order to search for metabolic biomarkers of antihypertensive drug responsiveness, we measured >600 biochemicals in plasma samples of subjects participating in the GENRES Study. Hypertensive men rec...
A cardioselective beta-1-adrenergic blocker. It is effective in the management of hypertension and angina pectoris.
A cardioselective beta-adrenergic blocker possessing properties and potency similar to PROPRANOLOL, but without a negative inotropic effect.
A condition in pregnant women with elevated systolic (>140 mm Hg) and diastolic (>90 mm Hg) blood pressure on at least two occasions 6 h apart. HYPERTENSION complicates 8-10% of all pregnancies, generally after 20 weeks of gestation. Gestational hypertension can be divided into several broad categories according to the complexity and associated symptoms, such as EDEMA; PROTEINURIA; SEIZURES; abnormalities in BLOOD COAGULATION and liver functions.
Hypertension due to RENAL ARTERY OBSTRUCTION or compression.
Increased pressure within the cranial vault. This may result from several conditions, including HYDROCEPHALUS; BRAIN EDEMA; intracranial masses; severe systemic HYPERTENSION; PSEUDOTUMOR CEREBRI; and other disorders.
Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...