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Iron Supplementation in TAVI and SAVR Patients With Iron Deficiency

NCT04786769 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2021-03-08

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis
  • Iron-deficiency

Interventions

DRUG

Ferric carboxymaltose

Intravenous ferric carboxymaltose according to baseline weight and hemoglobin

Sponsors & Collaborators

  • Hospital de Santa Cruz, Portugal

    lead OTHER

Principal Investigators

  • Afonso Félix-Oliveira, MSc · Hospital de Santa Cruz, Portugal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2025-01-31
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786769 on ClinicalTrials.gov