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

NCT ID: NCT00942487

Last Updated: 2009-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2009-07-31

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

Conditions

Primary Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Nebivolol

Group Type: EXPERIMENTAL

Nebilet

Intervention Type: DRUG

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

Metoprolol

Group Type: ACTIVE_COMPARATOR

Corvitol

Intervention Type: 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

Interventions

Nebilet

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

Intervention Type: DRUG

Corvitol

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Berlin-Chemie Menarini

INDUSTRY

Sponsor Role: lead

Responsible Party

University and Emergency Hospital of Bucharest

Principal Investigators

Dragos VINEREANU, MD

Role: PRINCIPAL_INVESTIGATOR

University and Emergency Hospital Bucharest, Romania

Locations

University and Emergency Hospital

Bucharest, , Romania

Countries

Romania

References

Vinereanu D, Madler CF, Gherghinescu C, Ciobanu AO, Fraser AG. Cumulative impact of cardiovascular risk factors on regional left ventricular function and reserve: progressive long-axis dysfunction with compensatory radial changes. Echocardiography. 2011 Sep;28(8):813-20. doi: 10.1111/j.1540-8175.2011.01456.x. Epub 2011 Aug 9.

Reference Type: DERIVED

PMID: 21827541 (View on PubMed)

Vinereanu D, Gherghinescu C, Ciobanu AO, Magda S, Niculescu N, Dulgheru R, Dragoi R, Lautaru A, Cinteza M, Fraser AG. Reversal of subclinical left ventricular dysfunction by antihypertensive treatment: a prospective trial of nebivolol against metoprolol. J Hypertens. 2011 Apr;29(4):809-17. doi: 10.1097/HJH.0b013e3283442f37.

Reference Type: DERIVED

PMID: 21297499 (View on PubMed)

Other Identifiers

MeRo/04/Neb-LVD/003

Identifier Type: -

Identifier Source: org_study_id