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

NCT00942487 | Completed Phase 3

• 1 other identifier: MeRo/04/Neb-LVD/003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Primary Arterial Hypertension

Keywords

arterial hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

Nebivolol

EXPERIMENTAL

Drug: Nebilet

Metoprolol

ACTIVE COMPARATOR

Drug: Corvitol

Interventions

Nebilet DRUG

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

Nebivolol

Corvitol 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

Metoprolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Berlin-Chemie Menarini: lead

Study Sites (1)

University and Emergency Hospital

Bucharest, 050098, Romania

Location

Related Publications (2)

• 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.

  PMID: 21827541 DERIVED

• 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.

  PMID: 21297499 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dragos VINEREANU, MD

  University and Emergency Hospital Bucharest, Romania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2009
• First Posted: July 21, 2009
• Study Start: April 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: July 1, 2009
• Last Updated: July 21, 2009

Record last verified: 2009-07

Locations

RO (1)