INERTIA: Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

Sponsor

Hospital de Santa Cruz, Portugal (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04786769

Collaborator

(none)

2,500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The INERTIA trial is a multicenter double-blinded randomized trial of intravenous iron supplementation in patients with severe aortic stenosis and iron deficiency undergoing TAVI or SAVR. The primary endpoint is the time to HF hospital admission or cardiovascular death. Secondary endpoints will assess quality of life indicators and functional capacity at 6 months.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis Iron-deficiency	Drug: Ferric carboxymaltose	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.Two-arm trial of intravenous iron supplementation vs placebo, randomized 1:1.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Clinical Trial of Intravenous Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iron supplementation Intravenous ferric carboxymaltose will be administered according to weight and hemoglobin values at randomization as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention (if determined by dose calculation, otherwise placebo) 12 weeks after valve intervention (if iron deficiency persists, otherwise placebo)	Drug: Ferric carboxymaltose Intravenous ferric carboxymaltose according to baseline weight and hemoglobin
Placebo Comparator: Placebo Intravenous 0.9% NaCl (placebo) will be administered as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention 12 weeks after valve intervention	Drug: Ferric carboxymaltose Intravenous ferric carboxymaltose according to baseline weight and hemoglobin

Arm

Intervention/Treatment

Experimental: Iron supplementation

Intravenous ferric carboxymaltose will be administered according to weight and hemoglobin values at randomization as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention (if determined by dose calculation, otherwise placebo) 12 weeks after valve intervention (if iron deficiency persists, otherwise placebo)

Drug: Ferric carboxymaltose

Intravenous ferric carboxymaltose according to baseline weight and hemoglobin

Placebo Comparator: Placebo

Intravenous 0.9% NaCl (placebo) will be administered as follows: 2-4 weeks before valve intervention On the day of admission to valve intervention 12 weeks after valve intervention

Drug: Ferric carboxymaltose

Intravenous ferric carboxymaltose according to baseline weight and hemoglobin

Outcome Measures

Primary Outcome Measures

Number of patients with heart failure hospital admission or cardiovascular death [up to 52 weeks]
Analyzed as time-to-event

Secondary Outcome Measures

Total number of allogeneic RBC units received [30 days post-TAVI or SAVR]
Walking distance [6 months post-TAVI or SAVR]
6 minute walking test
Kansas City Cardiomyopathy Questionnaire [6 months post-TAVI or SAVR]
Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.
Patient Global Assessment [6 months post-TAVI or SAVR]
Patient reported outcome on the impact of the disease in daily live
EQ-5D-5L [6 months post-TAVI or SAVR]
Quality of life assessment in five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Severe aortic stenosis
Enrolled for TAVI or SAVR procedures
Documented iron deficiency with either: Ferritin <100ug/L or Ferritin between 100-299ug/L and Transferrin Saturation < 20%.

Exclusion Criteria:

Use of packed red blood cells or whole blood in the past 3 months;
Use of erythropoietin-stimulating agent or IV iron in the past 3 months;
Use of oral or IV iron (>100mg/day) in the past 3 months;
Haemoglobin (Hb) levels > 15g/dL or < 8g/dL;
Active cancer;
Infection requiring antibiotic treatment at the time of first scheduled dose;
Any known contraindication to study intervention

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hospital de Santa Cruz, Portugal

Investigators

Principal Investigator: Afonso Félix-Oliveira, MSc, Hospital de Santa Cruz, Portugal

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Afonso Félix de Oliveira, Principal Investigator, Hospital de Santa Cruz, Portugal

ClinicalTrials.gov Identifier:

NCT04786769

Other Study ID Numbers:

UNICARV-1

First Posted:

Mar 8, 2021

Last Update Posted:

Mar 8, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Aortic Valve Stenosis

Anemia, Iron-Deficiency

Study Results

No Results Posted as of Mar 8, 2021