RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2025-05-01
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06929806

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Both women and men can join
  3. * Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity
  4. * Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less
  5. * Have low iron levels in the blood
  6. * New York Heart Association (NYHA) Heart Failure Classification II, III or IV
  1. * Planned cardiac surgery or revascularization or cardiac device implantation
  2. * Pregnant or nursing women
  3. * Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
  4. * Treatment with radiotherapy or chemotherapy

Contacts and Locations

Study Contact

Pharmacosmos Clinical and non-clinical Department
CONTACT
+45 5948 5959
info@pharmacosmos.com

Principal Investigator

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

Study Locations (Sites)

Private clinic
Pasadena, California, 91105
United States

Collaborators and Investigators

Sponsor: Pharmacosmos A/S

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2025-05-01
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Heart Failure
  • Iron Deficiencies