E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with severe aortic valve stenosis treated with Aortic Valve Replacement (AVR) |
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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 |
Primary objectives 1. In a consecutive population undergoing AVR for symptomatic AVS to compare a. LV mass index b. LA volume index c. plasma nt-pro BNP concentration after 12 months treatment with Atacand compared with conventional treatment
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E.2.2 | Secondary objectives of the trial |
1. In a consecutive population undergoing AVR for symptomatic AVS to compare: a. Echocardiographic diastolic E/e’ ratio b. Overall LV function assessed by the Doppler echocardiographic Tei Index d. Regional LV function assessed with echocardiographic tissue Doppler imaging e. LV end systolic and end diastolic volume index after 12 months treatment with Atacand compared with conventional treatment.
1. the occurence and atrial arrhythmias assessed with 48h Holther after 12 months treatment with Atacand compared with conventional management. 2. exercise capacity after 12 months treatment with Atacand compared with conventional management. 3. assess serial changes in LV diastolic, overall LV function and regional LV systolic function 12 months after valve replacement 4. assess serial changes in plasma nt-pro BNP, ANP, and renin 12 months after valve replacement
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Inclusion criteria 1. Symptomatic severe AVS referred for valve replacement (mechanic prosthesis or bioprosthesis) at Odense University Hospital 2. Age > 18 years 3. Signed informed consent
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E.4 | Principal exclusion criteria |
Exclusion criteria 1. Severe renal failure (s-creatinine >300 mmole/l) 2. Moderate or severe hepatic failure (ALAT >150 IU/l) 3. Moderate or severe LV systolic dysfunction (LVEF<40%) 4. Known intolerance for angiotensin II receptor antagonist (Atacand) 5. Unwilling to participate in the study 6. Poor echocardiographic window 7. Women of childbearing potential (only postmenopausal women) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end points Left ventricular mass index assessed by echocardiography, left atrial volume and N terminal pro brain natriuretic peptide concentration 12 months after valve replacement.
Secondary end point
Echocardiographic assessment of diastolic function, occurrence of atrial arrhytmias 12 months after AVR.
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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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | No |
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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Trial will end when the last included patient has been evaluated 12 months after enrollment. |
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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 | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |