Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: metoprolol succinate; Drug: Nebivolol

• Registration Number: NCT01248338
• Lead Sponsor: Berlin-Chemie AG Menarini Group

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2010-11
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-24
• Last Update Submitted: 2010-11-24
• Study First Posted: 2010-11-25
• Last Update Posted: 2010-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
metoprolol, tablets	metoprolol succinate	metoprolol succinate 50-100 mg orally daily for one year
nebivolol	Nebivolol	nebivolol 5 mg capsule once daily for one year

Primary Outcome Measures

Name	Time	Method
Effects of nebivolol and metoprolol on endothelial function	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in carotid artery intima-media thickness	12 months	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
Change in left ventricular mass index, systolic and diastolic function	12 months	2-dimensional echocardiography using the standard apical 4-chamber view
Arterial Compliance	12 months	Peripheral blood pressure and arterial waveform to be measured in the dominant arm by a Cardiovascular Profiling Instrument

Trial Locations

Locations (1)

Cardiology Clinic of Tartu University Clinics; 🇪🇪 Tartu, Estonia