Heart Failure With Preserved Ejection FractionPhase 4INFUSE-HFpEFNCT07686692
IV Iron Therapy for Older Adults With Heart Failure With Preserved Ejection Fraction and Iron Deficiency
A Phase 4 study testing Ferric derisomaltose in people with Heart Failure With Preserved Ejection Fraction and Iron Deficiency, run by Duke University at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Iron Deficiency
- What is being tested?
- Ferric derisomaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Aug 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Ambulatory adults age >=65 years with HFpEF (EF >50%)
- Hospitalized for HF in the past 12 months
- TSAT <20%
- Able to walk without assistance
Who cannot join
- Alternative etiologies of HFpEF syndrome:
- Uncorrected severe valvular heart disease
- Constrictive pericarditis
- High output HF
- Infiltrative cardiomyopathy
- Safety concerns for participation
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Health System
Durham, North Carolina, 27705
About this study
Official title: Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
- Being tested
- Ferric derisomaltose, Placebo (normal saline)
- Keywords
- Heart Failure with Preserved Ejection Fraction, Iron Deficiency, Ferric Derisomaltose
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric derisomaltoseDrug
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.
Placebo (normal saline)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ferric Derisomaltose | Experimental | Not described Receives: Drug: Ferric derisomaltose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.
Measured: 6 months
Secondary outcomes (1)
6-MWT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Marat Fudim, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686692
- Sponsor's protocol ID
- Pro00119548
- Other IDs
- 1R01AG097715
- Acronym
- INFUSE-HFpEF
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Needed for Function and Undesirable Symptoms in Elderly With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07686692
- Acronym / sponsor ID
- INFUSE-HFpEF / Pro00119548
- Keywords
- Heart Failure with Preserved Ejection Fraction, Iron Deficiency, Ferric Derisomaltose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA), Kaiser Permanente
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Derisomaltose | Experimental | Drug: Ferric derisomaltose |
| Placebo | Placebo comparator | Drug: Placebo (normal saline) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Ambulatory adults age >=65 years with HFpEF (EF >50%)
- Hospitalized for HF in the past 12 months
- TSAT <20%
- Able to walk without assistance
Key exclusion criteria (18 listed)
- Alternative etiologies of HFpEF syndrome:
- Uncorrected severe valvular heart disease
- Constrictive pericarditis
- High output HF
- Infiltrative cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric derisomaltoseIntravenous 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 | Ferric Derisomaltose |
| 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. | Drug | Placebo |
Primary outcome
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement.
Time frame: 6 months
1 secondary outcome
6-MWT
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marat Fudim principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric derisomaltose in people with Heart Failure With Preserved Ejection Fraction and Iron Deficiency, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hierarchical composite of mortality, all-cause hospitalization, and ≥5-point KCCQ-12 improvement. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.