IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Def… (NCT07686692) | Clinical Trial Compass
Not Yet RecruitingPhase 4
IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
United States300 participantsStarted 2026-08
Plain-language summary
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.