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

Information source: Berlin-Chemie Menarini
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Arterial Hypertension

Intervention: Nebilet (Drug); Corvitol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Berlin-Chemie Menarini

Official(s) and/or principal investigator(s):
Dragos VINEREANU, MD, Principal Investigator, Affiliation: University and Emergency Hospital Bucharest, Romania

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)

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes of: longitudinal myocardial velocities at rest (assessed by TDE), systolic functional reserve (calculated as the absolute and relative increase of the myocardial systolic velocities at peak stress from rest), NT-proBNP

Secondary outcome:

Global systolic function (ejection fraction)

Radial myocardial velocities

Right ventricular function

Global diastolic function

Left ventricular mass index

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 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University and Emergency Hospital, Bucharest 050098, Romania
Additional Information

Starting date: April 2005
Last updated: July 20, 2009

Page last updated: August 23, 2015

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