Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency (INERTIA)

March 4, 2021 updated by: Afonso Félix de Oliveira, Hospital de Santa Cruz, Portugal

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with heart failure hospital admission or cardiovascular death
Time Frame: up to 52 weeks
Analyzed as time-to-event
up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of allogeneic RBC units received
Time Frame: 30 days post-TAVI or SAVR
30 days post-TAVI or SAVR
Walking distance
Time Frame: 6 months post-TAVI or SAVR
6 minute walking test
6 months post-TAVI or SAVR
Kansas City Cardiomyopathy Questionnaire
Time Frame: 6 months post-TAVI or SAVR
Heart failure symptoms assessment. 0-100 scale, higher scores reflect better health status.
6 months post-TAVI or SAVR
Patient Global Assessment
Time Frame: 6 months post-TAVI or SAVR
Patient reported outcome on the impact of the disease in daily live
6 months post-TAVI or SAVR
EQ-5D-5L
Time Frame: 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.
6 months post-TAVI or SAVR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Santa Cruz, Portugal

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

March 2, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNICARV-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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