RECRUITING

Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Description

The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is: • How many participants are admitted to the hospital or die from a disease in the heart or blood vessels Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works. Participants will: * Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose * All participants receives standard of care * Visit site 4-5 times and have 7 video/phone-calls

Study Overview

Study Details

Study overview

The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is: • How many participants are admitted to the hospital or die from a disease in the heart or blood vessels Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works. Participants will: * Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose * All participants receives standard of care * Visit site 4-5 times and have 7 video/phone-calls

A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Condition
Chronic Heart Failure
Intervention / Treatment

-

Contacts and Locations

Pasadena

Private clinic, Pasadena, California, United States, 91105

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years or older
  • * Both women and men can join
  • * Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity
  • * Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less
  • * Have low iron levels in the blood
  • * New York Heart Association (NYHA) Heart Failure Classification II, III or IV
  • * Planned cardiac surgery or revascularization or cardiac device implantation
  • * Pregnant or nursing women
  • * Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
  • * Treatment with radiotherapy or chemotherapy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pharmacosmos A/S,

Pharmacosmos Clinical and non-clinical department, STUDY_DIRECTOR, Pharmacosmos A/S

Study Record Dates

2027-12-01