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Completed

NCT Number: NCT01248338

Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiology Clinic of Tartu University Clinics

Tartu, Estonia, 51014

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metoprolol succinate

Drug

once daily 50 or 100 mg for one year

Other names: Corvitol

nebivolol

Drug

once daily 5 mg capsule for one year

Other names: Nebilet

Primary outcomes

  1. Effects of nebivolol and metoprolol on endothelial function

    Time frame: 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 outcomes

  1. Change in carotid artery intima-media thickness

    Time frame: 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

  2. Change in left ventricular mass index, systolic and diastolic function

    Time frame: 12 months

    2-dimensional echocardiography using the standard apical 4-chamber view

  3. Arterial Compliance

    Time frame: 12 months

    Peripheral blood pressure and arterial waveform to be measured in the dominant arm by a Cardiovascular Profiling Instrument

Sponsors and collaborators

Lead sponsor

Berlin-Chemie AG Menarini Group

Industry

Registry information

Official study title

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

Acronym: NEMENDAS

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Nov 25, 2010
Registry last updated
Nov 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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