Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function (NEMENDAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248338
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : November 25, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: metoprolol succinate Drug: Nebivolol Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison the Effects of Nebivolol Versus Metoprolol Succinate on Endothelial Function and Large Artery Stiffness
Study Start Date : March 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Active Comparator: metoprolol, tablets
metoprolol succinate 50-100 mg orally daily for one year
Drug: metoprolol succinate
once daily 50 or 100 mg for one year
Other Name: Corvitol

Experimental: nebivolol
nebivolol 5 mg capsule once daily for one year
Drug: Nebivolol
once daily 5 mg capsule for one year
Other Name: Nebilet

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248338

Cardiology Clinic of Tartu University Clinics
Tartu, Estonia, 51014
Sponsors and Collaborators
Berlin-Chemie AG Menarini Group
Principal Investigator: Jaan Eha, Professor Cardiology Clinic of Tartu University Clinics

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kaltwasser, Maria Theresia, Dr., Berlin-Chemie AG Menarini Group Identifier: NCT01248338     History of Changes
Other Study ID Numbers: MeES/05/Neb-EnD/001
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: November 25, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists