Primary Arterial Hypertension
Conditions
Keywords
arterial hypertension
Brief summary
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
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
DRUGNebilet
Trade-mark: Nebilet® (Berlin-Chemie Menarini) INN: nebivolol Dosage and route of administration: 5 mg tablets, o.d. for oral administration
DRUGCorvitol
Trade-mark: Corvitol (Berlin-Chemie Menarini) INN: metoprolol Dosage and route of administration: 50 mg tablets, b.d. (100 mg/day) for oral administration
Sponsors
Berlin-Chemie Menarini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Romania
Outcome results
None listed