IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorDuke University
About this trial
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ambulatory adults age >=65 years with HFpEF (EF >50%)
Hospitalized for HF in the past 12 months
TSAT <20%
Able to walk without assistance
Disqualifiers
Uncorrected severe valvular heart disease
Constrictive pericarditis
High output HF
Infiltrative cardiomyopathy
Trial design
Design model
Parallel
Treatments tested in this trial
Ferric derisomaltose
DrugIntravenous ferric derisomaltose dose is determined by participant body weight and baseline hemoglobin and ranges from 500 mg to 2000 mg, administered as a single infusion.
Placebo (normal saline)
DrugTo preserve blinding, the normal saline placebo dose is also determined by participant body weight and baseline hemoglobin and ranges from 500 mg to 2000 mg, administered as a single infusion.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Ferric DerisomaltoseExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.
Time frame
6 monthsSecondary outcomes
1
6-MWT
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Aging (NIA)
Collaborator
Kaiser Permanente
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: