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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Berlin-Chemie Menarini
• Treatments: Metoprolol; Nebivolol

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