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Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction

NCT03074591 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-31

No results posted yet for this study

Summary

This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe

Conditions

Interventions

DRUG

Ferric Carboxymaltose 50Mg/Ml Inj 15Ml

After baseline assessments patients will be randomised in a 1:1 ratio to receive Ferric Carboxymaltose IV or placebo/saline (normal saline: 0.9% w/v NaCl). In the Treatment group, Ferric Carboxymaltose will be administered according to the dosing schedule.

DRUG

Saline Solution for Injection

In the placebo/saline group, patients will receive the aequivalent number of normal saline infusions.

Sponsors & Collaborators

  • University of Göttingen

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Stefan Anker, Prof · Charite University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2022-12-13
Completion
2024-04-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03074591 on ClinicalTrials.gov