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

Overview

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)

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2008

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

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Nebivolol
  • Active Comparator: Metoprolol

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Berlin-Chemie Menarini
  • Provider of Information About this Clinical Study
    • Professor Dragos VINEREANU, University and Emergency Hospital of Bucharest
  • Overall Official(s)
    • Dragos VINEREANU, MD, Principal Investigator, University and Emergency Hospital Bucharest, Romania

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