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

Intravenous Iron supplement for Iron deficiency in patients with Severe Aortic Stenosis - IIISAS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002037-11-NO

Enrollment

100

Registered

2019-08-06

Start date

2019-10-10

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency, aortic stenosis MedDRA version: 20.0 Level: HLT Classification code 10022971 Term: Iron deficiencies System Organ Class: 100000004861

Interventions

Trade Name: Monofer Product Name: Monofer Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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 ;Timepoint(s) of evaluation of this end point: 6 months after trial intervention	—

Measure

Time frame

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 ;Timepoint(s) of evaluation of this end point: 6 months after trial intervention

—

Countries

Norway

Contacts

Public ContactLars Gullestad

Oslo University Hospital

lars.gullestad@medisin.uio.no004723070000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026