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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ferric derisomaltose, an iron treatment given through a vein, against a placebo (no active treatment). It is for adults age 65 or older with low iron and heart failure with preserved ejection fraction (HFpEF), where the heart pumps well but does not fill normally.

This randomized, double-blind, placebo-controlled clinical trial evaluates intravenous ferric derisomaltose in older adults with HFpEF and iron deficiency.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 65 or older with HFpEF and an ejection fraction above 50% (the share of blood pumped out with each heartbeat).
  • Had a hospital stay for heart failure in the past 12 months.
  • Have transferrin saturation (TSAT), a blood test for available iron, below 20%.
  • Can walk without help.

Who can't join

  • Have another cause of heart failure: severe heart valve disease that has not been fixed; a stiff sac around the heart; heart failure with unusually high blood flow; or a buildup of substances in the heart muscle.
  • Have a safety concern about taking part, an allergy to any iron treatment given through a vein, or a history of too much iron in the body.
  • Have hemoglobin (the blood protein that carries oxygen) below 9 g/dL, above 13.5 g/dL for women, or above 15 g/dL for men; or had a hospital stay for bleeding in the digestive tract in the past 12 months.
  • Have an active infection, a disease that causes inflammation, or severe liver disease, such as active liver inflammation or liver scarring.
  • Use iron treatment through a vein now or used it in the past 4 weeks.
  • Have very poor kidney function (eGFR below 15 mL/min/1.73 m²) or long-term kidney disease treated with dialysis, which filters the blood.
  • Are expected to live less than 6 months, cannot give informed consent (agree to join after learning about the study), or are pregnant, breastfeeding, or planning pregnancy during the study.
  • Are in another study of an experimental drug or device, or took part in one within 30 days before this study's starting visit.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC