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

This study has been completed.
Sponsor:
Information provided by:
Berlin-Chemie Menarini
ClinicalTrials.gov Identifier:
NCT00942487
First received: July 19, 2009
Last updated: July 20, 2009
Last verified: July 2009
History of Changes

July 19, 2009
July 20, 2009
April 2005
December 2008   (final data collection date for primary outcome measure)
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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00942487 on ClinicalTrials.gov Archive Site
  • Global systolic function (ejection fraction) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Radial myocardial velocities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Right ventricular function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Global diastolic function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Left ventricular mass index [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol
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

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)

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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Primary Arterial Hypertension
  • Drug: Nebilet
    Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration
  • Drug: 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
  • Experimental: Nebivolol
    Intervention: Drug: Nebilet
  • Active Comparator: Metoprolol
    Intervention: Drug: Corvitol

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00942487
MeRo/04/Neb-LVD/003
No
Professor Dragos VINEREANU, University and Emergency Hospital of Bucharest
Berlin-Chemie Menarini
Not Provided
Principal Investigator: Dragos VINEREANU, MD University and Emergency Hospital Bucharest, Romania
Berlin-Chemie Menarini
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP