Hypertension Clinical Trial
Official title:
A Double Blind, 2:1 Randomised Monocentre Study to Investigate the Efficacy and Safety of Telmisartan (80 mg qd) Concerning the Amelioration of Structural Alterations and Function of Endothelium in Cardiovascular Risk Patients (SAFE-CRP: Structural Alterations and Function of Endothelium in Cardiovascular Risk Patients)
The aim of this trial is to evaluate the efficacy and safety of telmisartan 80 mg
administered once daily in patients with documented coronary artery disease (CAD) and a
probably cardiovascular risk profile concerning the amelioration of structural alterations
and endothelial function.
The primary objective of this trial is to evaluate the efficacy in particular with regard to
the percentage change of atheroma volume in the femoral artery.The secondary objective is to
evaluate the change in the plaque size- assessed by intravascular ultrasound, the increase
in Flow Dependent Dilation provoked by intraarterial infusion of three increasing
concentrations of Acetylcholine, and the change in seated systolic blood pressure.
Endothelial dysfunction is a primary event in atherogenesis and all known cardiovascular
risk factors have been associated with endothelial dysfunction before atherosclerotic
vascular disease manifests itself clinically. Pivotal to endothelial dysfunction is a
disturbance in the function of endothelium-derived nitric oxide (NO). Recently, it could be
shown that acute and chronic angiotensin-1 receptor antagonism reversed endothelial
dysfunction in atherosclerosis. In experimental atherosclerosis, AT1 receptor blockade
appears to have protective effects. Respective potential mechanisms include the prevention
of endothelial injury, the augmentation of NO activity, the inhibition of lipid peroxidation
and an antiproliferative effect. These findings together with the most recent data that
losartan improves endothelial function and NO activity suggest that AT1 receptor antagonism
may also be antiatherogenic in patients with atherosclerosis. Angiotensin II influences
smooth muscle cell migration, hyperplasia, and hypertrophy. Angiotensin II also enhances
production of local superoxide anion, which will inactivate nitric oxide. Inhibition of
these reactions by the AT1-Blocker telmisartan may therefore interfere with atherosclerotic
plaque formation.
Methodology:
2:1 randomised, double-blind and placebo-controlled parallel-group design
Planned/actual number of subjects:
Enrolled: 30/33, randomised: 30/22, completed: 30/15
Duration of treatment:
9 months: telmisartan (80 mg) or Placebo (80 mg)
Study Hypothesis:
The trial is designed as a group comparison of telmisartan 80 mg and placebo, where the
treatment groups are randomised in 2:1 relation, to investigate the efficacy of telmisartan
on structural alterations and endothelial dysfunction as measured as the percentage change
from baseline after 36 weeks of treatment of the atheroma volume in the femoral artery using
IVUS .
Secondary endpoints are the changes from baseline in the flow dependent dilatation after a
acetylcholine challenge which follows a nitro-glycerin bolus, the change of the total
atheroma volume, the percentage atheroma volume measured by intravascular ultrasound (IVUS)
and the infalmmatory parameters MCP-1, CRP, ox LDL antibodies and sPLA2 activity and amount.
In an analysis of covariance using baseline as covariate all endpoints will be investigated.
If the assumptions of normal distribution are not fulfilled, nonparametric methods will be
applied (Wilcoxon-Mann-Whitney test).
Comparison(s):
Placebo 80 mg
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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