E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lavt T3 syndrom. Vedvarende lave niveauer af T3 uden tilgrundliggende thyreoidealidelse hos patienter med hjertesvigt |
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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 | 10017353 |
E.1.2 | Term | Free T3 low |
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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 |
Ændringer i hjertefunktion ved behandling med syntetisk T3 til patienter med hjertesvigt og lavt T3 syndrom. |
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E.2.2 | Secondary objectives of the trial |
Ændringer i livskvalitet, neurohormonel dysfunktion og kropssammensætning ved behandling med syntetisk T3 til patienter med hjertesvigt og lavt T3 syndrom. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Kronisk stabil systolisk CHF (hjertesvigt), dvs. maksimalt optitreret konventionel behandling for CHF - Serum T3 ≤ 1.4 nmol/l målt 2 gange, normal TSH - EF ≤ 45 %, målt ved ekkokardiografi - Der udføres graviditetstest på fertile kvinder forud for forsøgsstart for at udelukke graviditet. For kvinder i den fertile alder kræves anvendelse af sikker antikonception i hele forsøgsperioden og minimum 1 uge efter afslutning af forsøget. Sikker antikonception omfatter p-piller, spiral, gestagendepotinjektion, subdermal implantation, hormonal vaginalring samt transdermal depotplaster.
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E.4 | Principal exclusion criteria |
- Kendt og behandlet thyreoideasygdom - Atrieflimren/flagren - Hyppige ventrikulære ekstrasystoler (mere end 20 %) eller løb af ventrikulære ekstrasystoler - Svær KOL bedømt ud fra anamnese og KOL medicinering (vedvarende/hyppigt behov for steroid inhalation) - Graviditet eller graviditetsønske - Alder < 18år
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E.5 End points |
E.5.1 | Primary end point(s) |
At undersøge effekten af T3 behandling på systolisk funktion af venstre ventrikel vurderet ved LVEF baseret på 3D-isotopkardiografi (MUGA-SPECT). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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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Studiet afsluttes uden yderligere follow-up, når alle deltagende patienter har været til det sidste planlagte besøg på hospitalet og har fået foretaget de sidste planlagte undersøgelser. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
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 |