E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS WITH HYPERTENSION AND LEFT-VENTRICULAR DYSFUNCTION INDUCED BY TACHYCARDIA |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the absolute change in LVEDD 4 weeks after start of treatment (visit 1 vs visit 3). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
treatment with IMP follows Electric Cardioversion |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The clinical part of the study is concluded after the planned number of patients has completed all phases of the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |