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

Study Overview
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Brief Summary
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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)

Detailed Description
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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

Official Title
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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

Conditions
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Primary Arterial Hypertension

Intervention / Treatment
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* Drug: Nebilet
* Drug: Corvitol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebivolol<br> | Drug: Nebilet<br>* Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration<br>|
| Active Comparator: Metoprolol<br> | Drug: Corvitol<br>* Trade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global systolic function (ejection fraction) |  | 6 months | 
| Radial myocardial velocities |  | 6 months | 
| Right ventricular function |  | 6 months | 
| Global diastolic function |  | 6 months | 
| Left ventricular mass index |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial hypertension