Not yet recruiting NCT07686692
IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferric derisomaltose, Placebo (normal saline).
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction, Iron Deficiency. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction
Overview
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
Interventions
- Drug Ferric derisomaltose
Intravenous 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. - Drug Placebo (normal saline)
To 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.
Primary outcome measures
- Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement. [Time frame: 6 months]
Secondary outcome measures (1)
- 6-MWT [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Ambulatory adults age >=65 years with HFpEF (EF >50%)
- Hospitalized for HF in the past 12 months
- TSAT <20%
- Able to walk without assistance
Exclusion criteria
- Alternative etiologies of HFpEF syndrome:
- Uncorrected severe valvular heart disease
- Constrictive pericarditis
- High output HF
- Infiltrative cardiomyopathy
- Safety concerns for participation
- Known hypersensitivity/allergy to any IV iron formulation
- History of iron overload (i.e., hemochromatosis)
- Hemoglobin <9 g/dL or >13.5 (women)/>15.0 (men) g/dL
- Hospitalized for GI bleed in past 12 months
- Active infection or inflammatory disease
- Severe liver disease (i.e., active hepatitis or known cirrhosis)
- Current or recent use (4 weeks) of IV iron therapy
- Severe renal impairment (i.e., eGFR <15 mL/min/1.73 m2 or Chronic Kidney Disease on dialysis)
- Estimated life expectancy <6 months
- Unable to provide informed consent
- Pregnancy, breastfeeding, or planned pregnancy during the study period
- Current participation in another investigational drug or device study; or participation in such a study within 30 days prior to baseline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Health System — Durham
Identifiers
NCT: NCT07686692 · Pro00119548 · 1R01AG097715