Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a single iron infusion ease heart failure in seniors?

NCT ID NCT07686692

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests whether a single intravenous dose of iron (ferric derisomaltose) can improve symptoms, reduce hospitalizations, and boost quality of life in adults aged 65 and older who have heart failure with preserved ejection fraction and iron deficiency. Participants receive either the iron infusion or a placebo, and researchers track outcomes like survival, hospital stays, and physical function over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferric derisomaltose (intravenous iron)
What this could lead to
If it works, this could offer a simple infusion to improve daily function and reduce hospital stays for older adults with heart failure and low iron.
What could go wrong
This is a single-dose study in a specific older population; results may not apply to all heart failure patients. Iron overload or allergic reactions are possible risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure with preserved ejection fraction are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

diastolic heart failure Iron Deficiencies iron deficiency anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure with preserved ejection fraction Iron-deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Health System

    Durham, North Carolina, 27705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.