COMPARISON OF THE EFFECTS OF COMBINED RATE- AND RHYTHM-CONTROL TREATMENT WITH NEBIVOLOL AND ELECTRIC CARDIOVERSION TO RATE-CONTROL TREATMENT WITH NEBIVOLOL ALONE ON CLINICAL AND ECHOCARDIOGRAPHIC PARAMETERS IN PATIENTS WITH HYPERTENSION AND LEFT-VENTRICULAR DYSFUNCTION INDUCED BY TACHYCARDIANEBICAR-TRIAL - Neb-Car-Trial

• Conditions: PATIENTS WITH HYPERTENSION AND LEFT-VENTRICULAR DYSFUNCTION INDUCED BY TACHYCARDIA

• Registration Number: EUCTR2004-004864-54-DE
• Lead Sponsor: Berlin-Chemie Menarini

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-05
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age >=18 years
• Newly occurring supraventricular tachycardia with a heart rate > 130 bpm within the last three months and initial treatment with Metoprolol and/or digitalis i.v.
• EF <= 50% after i.v. rate control treatment with Metoprolol and/or digitalis i.v.
• History of or new diagnosed arterial hypertension according to JNC
• Complete heparinisation
• Metoprolol and/or digitalis i.v.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Acute myocardial infarction
• Haemodynamic relevant heart valve disorders
• Left atrium diameter >= 55 mm
• Hyperthyroidism
• Contraindication to heparin including low-molecular-weight heparins, oral anticoagulation, Metoprolol, Nebivolol, digitalis or to cardioversion
• Concomitant treatment with antiarrhythmics
• Concomitant treatment with other beta-blockers after randomization except for Nebivolol as study medication
• Known hypersensitivity to Nebivolol or any of the ingredients of the trial medication or any known hypersensitivity to ß-blockers
• Patients with known SGPT (ALAT) and SGOT (ASAT) levels exceeding three times the upper limit of the investigator's normal range, known serum bilirubin > 1.75 mg/dl (> 30 µ mol/l) or clinical evidence of severe hepatic disease or hepatic failure
• Women of childbearing potential without adequate contraception (medically acceptable methods are contraceptive implant, contra- ceptive injection, intrauterine device (IUD), or oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study, or a double-barrier method which must consist of a combination of any of the following: diaphragma, cervical cap, condom, or spermicide)
• Patients who are pregnant or lactate (Pregnancy should be ruled out by pregnancy test)
• Cardiogenic Shock
• Peripheral arterial occlusive disease > IIa (PAOD) or Raynaud’s syndrome
• Severe cardiac decompensation as judged by the investigator and/or NYHA class IV
• Sick-sinus-syndrome including heart blocks (SA node) and/or AV block 2nd and 3rd degree and/or significant arrhythmia and/or bradycardia < 50 bpm (in resting condition prior to treatment)
• Bronchial hyperreagibility, bronchial asthma, or history of bronchospasm
• Untreated pheocromocytoma
• Metabolic acidosis
• Prior or active malignancy in the previous 5 years except adequately treated basal cell/ squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Hypotension with systolic blood pressure < 85 mmHg
• Patients with psychiatric diseases
• Patients with a history of alcohol and/or drug abuse
• Patients who are currently participating in another clinical study or who have received an investigational drug within 30 days prior to entering the study
• Patients who are unwilling or unable to provide informed consent or to participate satisfactorily for the entire trial period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified