Overview

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