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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014