Primary Arterial Hypertension Clinical Trial
Official title:
Effects of NEbivolol on Subclinical Left Ventricular dYSfunction. A Comparative Study Against Metoprolol. The ENESYS Study. A Phase 3, Randomised, Parallel, Active-controlled, Open Label Study
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment