Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol

Overview

Summary: * Study title: Effects of Nebivolol on subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS study) * Study phase: 3 * Study design (parallel, cross-over, etc.), randomisation and blinding procedures, type of control (placebo or active): randomised, parallel, active-controlled, open label * Study treatment(s)/drug(s): Nebivolol versus Metoprolol * Patients: * characteristics: patients with hypertension and left ventricular hypertrophy * planned total number: 50 * Study duration: * total enrolment period (months): 18 * treatment period (months): 6 * follow up period (months): 6 * Total study duration (months): 24 * Number of Centres: 1 * Country(ies): Romania (RO)

STUDY OBJECTIVES 1. PRIMARY: * Longitudinal myocardial velocities at rest (assessed by tissue Doppler echocardiography) * Systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest) * Brain natriuretic peptide (BNP, NT-pro BNP) after a 6-months period of treatment with nebivolol versus metoprolol. An improvement of more than 20% of the myocardial resting velocities of systolic functional reserve is considered to be clinically relevant. The working hypothesis is that the improvement of subclinical left ventricular dysfunction after 6 months of treatment is going to be greater in patients who receive nebivolol than in those who receive metoprolol. 2. SECONDARY: * Global systolic function (ejection fraction) * Radial myocardial velocities * Right ventricular function * Global diastolic function * Left ventricular mass index