Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function

Hypertension Clinical Trial

— NEMENDAS  

Official title:

Comparison the Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function and Large Artery Stiffness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248338
• Other study ID #: MeES/05/Neb-EnD/001
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2010
• Last updated: November 24, 2010
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: November 2010
• Source: Berlin-Chemie AG Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of Medicine
• Study type: Interventional

Clinical Trial Summary

An impairment of endothelial function plays the central role in the pathogenesis of cardiovascular diseases and their complications. Most of cardiovascular risk factors are known to impair endothelial function and the established disease further aggravates endothelial dysfunction.

The aim of the present study is to investigate the effects of nebivolol or metoprolol succinate on endothelial function and large artery stiffness.

Description:

The aim of this study was to compare the effects between the vasodilating β-blocker nebivolol and the cardioselective β-blocker metoprolol succinate on aortic blood pressure and left ventricular wall thickness. We conducted a randomized, double-blind study in 80 hypertensive patients. Patients received either nebivolol 5 mg or metoprolol succinate 50-100 mg daily for one year. Their heart rate, central and brachial blood pressure, mean arterial pressure, augmentation index, carotid-femoral pulse wave velocity and left ventricular wall thickness were measured at baseline and at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with mild to moderate essential hypertension (systolic BP 140-179 mmHg and/or diastolic BP 90-109 mmHg)*

• Male and female patients aged 30-65 years Newly diagnosed untreated patients or previously diagnosed patients who were without treatment at least two weeks prior to screening* If patient has been taken previously antihypertensive medication the BP values are originated after untreated two weeks before randomization

Exclusion Criteria:

• Concomitant medication: Cyclic antidepressants, MAO inhibitors, corticosteroids

• Diabetes I or II type (fasting venous plasma glucose > 6.4 mmol/l)

• Bronchial asthma and chronic obstructive airway disease

• Body mass index > 30 kg/m2

• Ischaemic heart disease (III, IV stage, Canadian Cardiovascular Society)

• Clinically relevant heart failure (NYHA class II - IV)

• Clinically relevant valve disease (physical examination)

• Arrhythmias and conduction disturbances, requiring therapy, sinus bradycardia at rest < 50 b/min, sick sinus syndrome, AV - block stage II - III

• Secondary hypertension (urea >8.3 mmol/l, creatinine >120µmol/l (males), >103 µmol/l (females), TSH > 4.0mIU/l, free T4 > 27 pmol/l)

• Clinically relevant atherosclerotic disease of lower extremities

• Acute inflammation (according to CRP > 10mg/l)

• Hypercholesterolemia (> 6,5 mmol/l)

• Allergic reaction to beta-blockers

• Pregnant or breast-feeding women

• History of hepatic, renal, metabolic or endocrine diseases

• Smoking > 10 cigarettes per day

• Alcohol consumption > 7 drinks per week (drink = 0,33 l beer, 120 ml wine or 30 ml strong alcoholic drink)

• The patient has had surgery or disease of the gastrointestinal tract which, in the opinion of the investigator, may influence the absorption or elimination of the study drug.

• The patient has a severe organic disorder that may interfere with the absorption, pharmacokinetics, or elimination of the study medication.

• The patient has a comorbid condition that would be expected to result in death during the trial period (e.g., terminal cancer, AIDS).

• The patient has chronic psychoses or behavioural conditions that would limit the ability of the patient to comply with the requirements of this study.

• The patient has known hypersensitivity to Nebivolol, Metoprolol or hydrochlorothiazide related compounds.

• Patient is enrolled in another clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• metoprolol succinate
once daily 50 or 100 mg for one year
• Nebivolol
once daily 5 mg capsule for one year

Locations

Country	Name	City	State
Estonia	Cardiology Clinic of Tartu University Clinics	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
Berlin-Chemie AG Menarini Group

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of nebivolol and metoprolol on endothelial function	High-fidelity micromanometer (applanation tonometry) from both wrists and PWA, which is to be performed of the systolic portion (SphygmoCor Px, version 7.0) of the pulse curve.	12 months	No
Secondary	Change in carotid artery intima-media thickness	Ultrasound scanner,with an 12 MHz transducer. Longitudinal images from 3 projections (anterolateral, lateral, and posterolateral) are measured for the common carotid artery, carotid bulb, and internal carotid artery	12 months	No
Secondary	Change in left ventricular mass index, systolic and diastolic function	2-dimensional echocardiography using the standard apical 4-chamber view	12 months	No
Secondary	Arterial Compliance	Peripheral blood pressure and arterial waveform to be measured in the dominant arm by a Cardiovascular Profiling Instrument	12 months	No