PATIENTS WITH HYPERTENSION AND LEFT-VENTRICULAR DYSFUNCTION INDUCED BY TACHYCARDIA
Conditions
Interventions
Product Name: Nebilet
Pharmaceutical Form: Tablet
INN or Proposed INN: Nebivolol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Sponsors
Berlin-Chemie Menarini
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Left ventricular end systolic diameter (LVESD) - Ejection fraction (EF). - Influence of the treatment on further echocardiographic parameters - To assess the response to treatment (overall and response to cardioversion) - To compare the influence of the treatment with Nebivolol following ECV with biphasic waveform shocks to the treatment with Nebivolol alone on clinical parameters of heart failure - To compare the influence of the treatment with Nebivolol following ECV with biphasic waveform shocks to the treatment with Nebivolol alone on NT-proBNP (N-terminal-pro-B-type natriuretic peptide) - To assess the bioimpedance and energy load of electric cardioversion with biphasic wave shocks in dependence of weight;Primary end point(s): The primary endpoint is the absolute change in LVEDD 4 weeks after start of treatment (visit 1 vs visit 3). ;Main Objective: To compare the influence of the treatment with Nebivolol following ECV with biphasic waveform shocks to the treatment with Nebivolol alone on the echocardiographic parameters left ventricular enddiastolic diameter (LVEDD). | — |
Countries
Germany
Outcome results
None listed