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

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ClinicalTrials.gov Identifier: NCT00942487
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : July 21, 2009
Sponsor:
Information provided by:

Study Description
Brief 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)

Condition or disease Intervention/treatment Phase
Primary Arterial Hypertension Drug: Nebilet Drug: Corvitol Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2005
Primary Completion Date : December 2008
Study Completion Date : July 2009


Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Global systolic function (ejection fraction) [ Time Frame: 6 months ]
  2. Radial myocardial velocities [ Time Frame: 6 months ]
  3. Right ventricular function [ Time Frame: 6 months ]
  4. Global diastolic function [ Time Frame: 6 months ]
  5. Left ventricular mass index [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 21, 2009    Key Record Dates
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by Berlin-Chemie Menarini:
arterial hypertension

Additional relevant MeSH terms:
Hypertension
Ventricular Dysfunction
Ventricular Dysfunction, Left
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Metoprolol
Nebivolol
Anti-Arrhythmia Agents
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
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists