E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency, aortic stenosis |
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E.1.1.1 | Medical condition in easily understood language |
Iron deficeincy, aortic valve narrowing |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10022971 |
E.1.2 | Term | Iron deficiencies |
E.1.2 | System Organ Class | 100000004861 |
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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 |
The main goal of this study is to evaluate the effect of a single dose of intravenous iron isomaltoside on exercise capacity after transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis and iron deficiency. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess the impact of treatment on: (i) iron stores, (ii) muscle strength, (iii) body composition, (iv) cognitive function, (v) quality of life, (vi) myocardial structure and function, (vii) markers of myocardial disease and inflammation, and (viii) safety and tolerability. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with aortic stenosis with peak flow velocity (>3.5 m/s) scheduled for aortic valve replacement with transcatheter aortic valve implantation
Iron deficiency defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %.
Age > 18 years.
Signed informed consent and expected compliance with protocol.
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E.4 | Principal exclusion criteria |
Contraindications to study medication.
Failure to obtain written informed consent
Inability to walk at least 100 meters over 6 minutes
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: The primary endpoint will be the baseline-adjusted distance walked on a 6 min walk test performed 6 months after the trial intervention. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after trial intervention |
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E.5.2 | Secondary end point(s) |
Secondary endpoints:
• Iron deficiency defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %.
• Muscle strength as measured by a hand-grip device
• Quality of life as assessed by the SF-36, EQ 5D 3L, EQ-VAS, HADS and KCCQ questionnaires
• Myocardial structure and function
• Cognitive function as assessed by the CANTAB battery
• N-terminal pro-B-type natriuretic peptide (NT-proBNP)
• Cardiac troponin T (TnT)
• C-reactive protein (CRP)
• Inflammatory and vasoactive peptides
• Complications during TAVI procedures
• Safety
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months after trial intervention |
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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 | Yes |
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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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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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 | 3 |
E.8.9.1 | In the Member State concerned days | |