patients with metabolic syndrome, mild to moderate hypertension and without overt coronary artery disease
Conditions
Interventions
Trade Name: Kinzalmono 40 mg Tabletten
Product Name: Kinzalmono 40 mg Tabletten
Product Code: BAY 68-9291
Pharmaceutical Form: Tablet
INN or Proposed INN: telmisartan
Concentration unit: mg milligram(
Sponsors
3.Med. Department, Academic Hospital Bogenhausen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with metabolic syndrome, • both sexes, • age 30 – 80 years, • mild to moderate hypertension potentially on treatment, • normo- or hyperlipidemia potentially on statin therapy, • normal systolic LV function, • in sinusrhythm, • patient agreement signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • contraindications for either telmisartan or amlodipin • malignant hypertension • major complications of macrovascular disesase, • overt coronary artery disease, • patients, who lack inclusion criteria • manifest drug or alcohol abuse or psychiatric disease (such as depression, schizophrenia, anorexia nervosa) • malignat disease and other severe disease (such as liver cirrhosis, chronic infectious disease) which could interfere with interpretation of blood chemistry data or ultrasound data • participation in another study simultaneously
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of diastolic myocardial function after 12 weeks oral treatment with telmisartan in comparison with amlodipin in patients with metabolic syndrome, mild to moderate hypertension and without overt coronary artery disease.;Secondary Objective: Additional objectives will be the comparison of telmisartan with amlodipin with respect to change from baseline in parameters of LV systolic and diastolic function, intima-media thickness, vascular function, LV and LA size and filling pressures and, additionally, of HbA1c, fasting plasma glucose and insulin, lipids, CRP, nitrotyrosine and antioxidative capacity and the effects of temisartan and amlodipin on these parameters after 12 weeks therapy.;Primary end point(s): Primary study endpoint is the pleiotropic effect of telmisartan compared to amlodipine each at the end of the 12 weeks treatment period. This is expressed as diastolic myocardial function (Ve) measured by tissue Doppler. Additional endpoints are: Change from baseline (week 0) of the following parameters after 12 weeks of treatment with telmisartan (or amlodipin): • Myocardial systolic velocity Vs (cm/s) • LV enddiastolic diameter (mm) • LA endsystolic diameter (mm) • Traditional parameters of diastolic function from mitral inflow (E and A velocity , cm/s) • LV filling pressure (calculated E/Vd)(23) • vascular function: intima-media thickness, stiffness index, pulse wave velocity, wave intensity • Hemodynamic variables: Systolic and diastolic blood pressure (mmHg), pulse pressure, rate pressure product and heart rate • Laboratory parameters: HbA1c, fasting plasma glucose and insulin, lipid profile, CRP, nitrotyrosine and antioxidative capacity | — |
Countries
Germany
Outcome results
None listed