NCT07686692Not yet recruitingPhase 4
IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 30 Jun 2026
- Start date
- Nov 2026
- Primary completion date
- Aug 2030
- Lead sponsor
- Duke University
- Diseases
- Heart failure
- NCT number
- NCT07686692
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 300
- From Nov 2026 to the primary completion date, Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent use (4 weeks) of IV iron therapy
- Current participation in another investigational drug or device study; or participation in such a study within 30 days prior to baseline
Other illness
- Alternative etiologies of HFpEF syndrome:
- Uncorrected severe valvular heart disease
- Known hypersensitivity/allergy to any IV iron formulation
- History of iron overload (i.e., hemochromatosis)
- Active infection or inflammatory disease
- Severe liver disease (i.e., active hepatitis or known cirrhosis)
Lab values
- Hemoglobin \<9 g/dL or \>13.5 (women)/\>15.0 (men) g/dL
- Severe renal impairment (i.e., eGFR \<15 mL/min/1.73 m2 or Chronic Kidney Disease on dialysis)
Other
- Constrictive pericarditis
- High output HF
- Infiltrative cardiomyopathy
- Safety concerns for participation
- Hospitalized for GI bleed in past 12 months
- Estimated life expectancy \<6 months
- Unable to provide informed consent
- Pregnancy, breastfeeding, or planned pregnancy during the study period
Who the study is looking for
- Ambulatory adults age \>=65 years with HFpEF (EF \>50%)
- Hospitalized for HF in the past 12 months
- TSAT \<20%
- Able to walk without assistance
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Health System Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.