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Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

NCT03037931 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3065

Last updated 2024-07-03

Study results available
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Summary

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

Conditions

Interventions

DRUG

Ferric Carboxymaltose

Intravenous Iron

DRUG

Placebo

Normal Saline Solution

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • American Regent, Inc.

    lead INDUSTRY

Principal Investigators

  • Adrian F Hernandez, MD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-15
Primary Completion
2023-02-02
Completion
2023-02-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Georgia
  • Hungary
  • Latvia
  • Lithuania
  • New Zealand
  • Poland
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
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 NCT03037931 on ClinicalTrials.gov