Trial | NCT00942487  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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

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.

SECONDARY:

Global systolic function (ejection fraction)
Radial myocardial velocities
Right ventricular function
Global diastolic function
Left ventricular mass index
Study Started
Apr 30
2005
Primary Completion
Dec 31
2008
Study Completion
Jul 31
2009
Last Update
Jul 21
2009
Estimate

Drug Nebilet

Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration

Drug Corvitol

Trade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration

Nebivolol Experimental

Metoprolol Active Comparator

Criteria 

Inclusion Criteria:

aged 18 years or older, men and women, hospitalized and outpatients
with a history of primary arterial hypertension
with a daytime ambulatory blood pressure >140 and/or >90 mm Hg
with left ventricular hypertrophy: LVMI > 125 g/m2 for men, and > 110 g/m2 for women, by Devereux formula, as recommended by the ESH-ESC guidelines (14)
in sinus rhythm
consented, by signing the Informed Consent

Exclusion Criteria:

Severe arterial hypertension (systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg)
Any history of coronary heart disease (stable angina, acute coronary syndromes, myocardial infarction)
Any history of cerebrovascular disease
Renal impairment (creatinine > 1.5 mg% for men, > 1.4 mg% for women)
Left ventricular global systolic dysfunction (EF < 45%)
More than mild valvar (mitral or aortic) regurgitation
Hypertrophic cardiomyopathy
Pericarditis
Cor pulmonale
Pregnancy or lactating women
Any significant co-morbidities
Contraindication to beta-blocker therapy
Concomitant treatment with other beta-blockers
Participation to another investigational study in the last 3 months
No Results Posted