Status:
COMPLETED
Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol
Lead Sponsor:
Berlin-Chemie Menarini
Conditions:
Primary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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,...
Detailed Description
STUDY OBJECTIVES 1. PRIMARY: * Longitudinal myocardial velocities at rest (assessed by tissue Doppler echocardiography) * Systolic functional reserve (calculated as the absolute and relative i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00942487
Start Date
April 1 2005
End Date
July 1 2009
Last Update
July 21 2009
Active Locations (1)
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1
University and Emergency Hospital
Bucharest, Romania, 050098