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

Berlin Chemie

Status and phase: Completed; Phase 3

Conditions: Primary Arterial Hypertension

Treatments: Drug: Corvitol; Drug: Nebilet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00942487

MeRo/04/Neb-LVD/003

Details and patient eligibility

About

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 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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Nebivolol

Experimental group

Treatment:

Drug: Nebilet

Metoprolol

Active Comparator group

Treatment:

Drug: Corvitol