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

July 20, 2009 updated by: Berlin-Chemie Menarini

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 050098
        • University and Emergency Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebivolol
Drug: Nebilet
Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration
Active Comparator: Metoprolol
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Global systolic function (ejection fraction)
Time Frame: 6 months
6 months
Radial myocardial velocities
Time Frame: 6 months
6 months
Right ventricular function
Time Frame: 6 months
6 months
Global diastolic function
Time Frame: 6 months
6 months
Left ventricular mass index
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Berlin-Chemie Menarini

Investigators

  • Principal Investigator: Dragos VINEREANU, MD, University and Emergency Hospital Bucharest, Romania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 19, 2009

First Submitted That Met QC Criteria

July 20, 2009

First Posted (Estimate)

July 21, 2009

Study Record Updates

Last Update Posted (Estimate)

July 21, 2009

Last Update Submitted That Met QC Criteria

July 20, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MeRo/04/Neb-LVD/003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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