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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
  Purpose

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)

Condition Intervention Phase
Primary Arterial Hypertension
 Drug: Nebilet
Drug: Corvitol
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Berlin-Chemie Menarini:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: April 2005
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942487

Locations
Romania
University and Emergency Hospital
Bucharest, Romania, 050098
Sponsors and Collaborators
Berlin-Chemie Menarini
Investigators
Principal Investigator: Dragos VINEREANU, MD University and Emergency Hospital Bucharest, Romania
  More Information

No publications provided by Berlin-Chemie Menarini

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Dragos VINEREANU, University and Emergency Hospital of Bucharest
ClinicalTrials.gov Identifier: NCT00942487     History of Changes
Other Study ID Numbers: MeRo/04/Neb-LVD/003
Study First Received: July 19, 2009
Last Updated: July 20, 2009
Health Authority: Romania: National Drug Agency

Keywords provided by Berlin-Chemie Menarini:
arterial hypertension

Additional relevant MeSH terms:
Hypertension
Ventricular Dysfunction, Left
Ventricular Dysfunction
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013