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Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction

NCT05477498 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2022-07-28

No results posted yet for this study

Summary

This study aims to investigate the effects of treatment with intravenous ferric carboxymaltose on exercise tolerance measured as VO2peak in patients with HFpEF and iron deficiency, compared to placebo.

Conditions

  • Heart Failure With Normal Ejection Fraction
  • Iron-deficiency

Interventions

DRUG

Ferric carboxymaltose

Application of FCM solution (Ferinject®, Vifor Pharma AG, Villars-sur-Glâne, Switzerland) by intravenous injection.

DRUG

Placebo

Application of placebo solution administered as normal saline (0.9% weight/volume (w/v) NaCl) by intravenous injection as per the instructions for active treatment.

Sponsors & Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER

  • Cantonal Hosptal, Baselland

    lead OTHER

Principal Investigators

  • Thomas Dieterle, MD · University Department of Internal Medicine, Cantonal Hospital Baselland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-08-31
Completion
2022-12-31

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Drugs

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 NCT05477498 on ClinicalTrials.gov