E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Aortaklapsstenose Diastolisk dysfunktion
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002906 |
E.1.2 | Term | Aortic stenosis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052337 |
E.1.2 | Term | Diastolic dysfunction |
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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 |
At vurdere effekten af præoperativ behandling med levosimendan hos patienter, der skal aortaklapopereres (AVR) ved: 1) Ekkokardiografiske mål for hjertets diastoliske funktion med måling af longitudinelle myokardiehastigheder og transmitrale flowhastigheder før, under og efter operation.
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E.2.2 | Secondary objectives of the trial |
At vurdere effekten af præoperativ behandling med levosimendan hos patienter, der skal aortaklapopereres (AVR) ved: 1) Hæmodynamiske mål for hjerte-karsystemet vha. pulmonalarteriekateter (Swan Ganz kateter) med måling før, under og efter operation. 2) Ekkokardiografiske mål for hjertets systoliske funktion med måling af radial og longitudinel deformering af myokardiet (strain) før, under og efter operation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Opfylder kriterier for udskiftning af aortaklappen EF > 45% Tykkelse af venstre ventrikels bagvæg > 12mm Har sinusrytme
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E.4 | Principal exclusion criteria |
Indstilling til samtidig bypass operation Svær mitralinsufficiens Aktiv endokarditis Utilstrækkeligt ultralydsvindue, som vurderet ved projektleder Systolisk blodtryk < 100. Kendt allergi over for levosimendan Moderat til svær nyreinsufficiens defineret som kreatinin > 170 mmol/l eller kreatininclearance < 30 ml/min. Manglende patientsamtykke' Gravide eller ammende kvinder Kvinder i den fertile alder, og som fortsat er fertile og seksuelt aktive, der ikke anvender antikonception.
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E.5 End points |
E.5.1 | Primary end point(s) |
1) E/E’(vævsDoppler transthorakal ekkokardiografi) grupperne imellem ved T2 & T5 (refererer til tidspunkter nævnt i forsøgsprotokol).
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Systolic & diastolic function |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | Yes |
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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Forsøget ender, når sidste deltager har fået foretaget sidste ekkokardiografi. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |