Intravenous iron supplement for patients with severe aortic stenosis who have iron deficiency

Phase 1

• Conditions: Iron deficiency, aortic stenosis; MedDRA version: 20.0 Level: HLT Classification code 10022971 Term: Iron deficiencies System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-002037-11-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 100

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Contraindications to study medication.
Failure to obtain written informed consent
Inability to walk at least 100 meters over 6 minutes

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: 6 months after trial intervention

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): Secondary endpoints: <br> •Iron deficiency defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %. <br> •Muscle strength as measured by a hand-grip device<br> •Quality of life as assessed by the SF-36, EQ 5D 3L, EQ-VAS, HADS and KCCQ questionnaires<br> •Myocardial structure and function<br> •Cognitive function as assessed by the CANTAB battery<br> •N-terminal pro-B-type natriuretic peptide (NT-proBNP)<br> •Cardiac troponin T (TnT)<br> •C-reactive protein (CRP)<br> •Inflammatory and vasoactive peptides<br> •Complications during TAVI procedures<br> •Safety<br> ;Timepoint(s) of evaluation of this end point: 6 months after trial intervention