The primary objective was to show that telmisartan is not inferior to metoprolol succinate in respect of the percentage change from baseline in LVMI(H) after a 6.5 months treatment period. As secondary objectives, the improvement in left ventricular systolic and diastolic function and blood pressure reduction were assessed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Percentage change in left ventricular mass index relative to height (LVMI(H))
based on LVM measurements by magnetic resonance imaging (MRI)
Time frame: Baseline, day 180
Number of patients with adverse events
Time frame: up to 6.5 months
Change of left ventricular mass index related to the body surface area (LVMI (BSA)) measured by MRI
Time frame: Baseline, day 180
Change of left ventricular end-systolic (LVESV) measured by MRI
Time frame: Baseline, day 180
Change of left ventricular end-diastolic volume (LVEDV) as measured by MRI
Time frame: Baseline, day 180
Change of left ventricular end-diastolic volume index related to height LVEDVI (H))
based on LV volumetric measurements by MRI
Time frame: Baseline, day 180
Change of left ventricular end-diastolic volume index related to the body mass index (LVEDVI (BSA))
based on LV volumetric measurements by MRI
Time frame: Baseline, day 180
Change of left ventricular ejection fraction (EF)
based on LV volumetric measurements by MRI
Time frame: Baseline, day 180
Change of end-systolic wall stress (ESWS) measured by MRI
Time frame: Baseline, day 180
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Change of 24-hour mean systolic blood pressure measured by ambulatory blood pressure monitoring (ABPM)
Time frame: Baseline, day 179
Change of 24-hour mean diastolic blood pressure as measure by ABPM
Time frame: Baseline, day 179
Change of mean seated trough systolic blood pressure measured by manual cuff sphygmomanometer
Time frame: up to day 194
Change of mean seated trough diastolic blood pressure measured by manual cuff sphygmomanometer
Time frame: up to day 194