Effects of Nebivolol on Subclinical Left Ventricular dySfunction: A Comparative Study Against Metoprolol
- Registration Number
- NCT00942487
- Lead Sponsor
- Berlin-Chemie Menarini
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metoprolol Corvitol - Nebivolol Nebilet -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
University and Emergency Hospital
🇷🇴Bucharest, Romania