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Completed

NCT Number: NCT00942487

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

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)

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Key information

Conditions

Primary Arterial Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University and Emergency Hospital

Bucharest, 050098, Romania

About this study

STUDY OBJECTIVES

  • 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.
  • SECONDARY:
  • Global systolic function (ejection fraction)
  • Radial myocardial velocities
  • Right ventricular function
  • Global diastolic function
  • Left ventricular mass index

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nebilet

Drug

Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration

Corvitol

Drug

Trade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Berlin-Chemie Menarini

Industry

Registry information

Official study 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

Acronym: ENESYS

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jul 21, 2009
Registry last updated
Jul 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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