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

Primary Arterial Hypertension Clinical Trial

— ENESYS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942487
• Other study ID #: MeRo/04/Neb-LVD/003
• Status: Completed
• Phase: Phase 3
• First received: July 19, 2009
• Last updated: July 20, 2009
• Start date: April 2005
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Berlin-Chemie Menarini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Drug Agency
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hypertension
• Primary Arterial Hypertension
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

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

Locations

Country	Name	City	State
Romania	University and Emergency Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Berlin-Chemie Menarini

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months	Yes
Secondary	Global systolic function (ejection fraction)		6 months	Yes
Secondary	Radial myocardial velocities		6 months	Yes
Secondary	Right ventricular function		6 months	Yes
Secondary	Global diastolic function		6 months	Yes
Secondary	Left ventricular mass index		6 months	Yes