Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04945707

Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)

Led by Massachusetts General Hospital · Updated on 2026-02-19

66

Participants Needed

1

Research Sites

244 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective of this study is to determine if the correction of functional iron deficiency by administering a single dose of intravenous iron (ferric derimaltose or Monoferric®) in participants with heart failure with preserved ejection fraction (HFpEF) will improve exercise capacity as measured by the change in peak oxygen uptake (peak VO2) from baseline to 12 weeks.

CONDITIONS

Official Title

Impact of Intravenous Iron Repletion On Mechanisms of Exercise InTolerance in HFpEF (IRONMET-HFpEF)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult 18 years or older able to provide informed consent
  • Stable heart failure (NYHA class II-IV) for at least 4 weeks
  • Heart failure with preserved left ventricular ejection fraction (LVEF 65%) measured within 6 months
  • NT-proBNP 65 125 pg/mL without atrial fibrillation/flutter, or 65 250 pg/mL with ongoing atrial fibrillation/flutter, or history of elevated pulmonary capillary wedge pressure, or recent heart failure hospitalization within 12 months, or chronic diastolic dysfunction on echocardiogram
  • Hemoglobin greater than 9.0 g/dL and less than 15.0 g/dL
  • Serum ferritin less than 100 ng/mL, or 100 to 300 ng/mL with transferrin saturation (TSAT) less than 20%, but not ferritin less than 15 ng/mL
  • Reduced exercise capacity with peak VO2 64 75% of predicted on cardiopulmonary exercise test (CPET)
  • Able to perform maximal effort CPET with respiratory exchange ratio (RER) 65 1.05
Not Eligible

You will not qualify if you...

  • Current or planned intravenous iron supplementation; iron-containing multivitamins less than 30 mg/day are allowed
  • Known allergy to ferric derisomaltose (Monofer)
  • History of acquired iron overload or recent erythropoietin, IV iron therapy, or blood transfusion within 3 months
  • Active gastrointestinal bleeding
  • Anemia caused by conditions other than iron deficiency or chronic disease
  • Acute heart events (myocardial infarction, acute coronary syndrome, stroke, transient ischemic attack) within 3 months
  • Conditions preventing exercise testing such as claudication, uncontrolled arrhythmias, significant musculoskeletal disease, severe obesity (BMI over 50 kg/m2), or other primary exercise limitations
  • Severe kidney dysfunction (eGFR less than 20 ml/min/1.73m2)
  • Severe liver disease (elevated liver enzymes or bilirubin)
  • Active cancer except non-melanoma skin cancer
  • Women of child-bearing potential who are pregnant, breastfeeding, or unwilling to use contraception during the study and for 5 days after last dose
  • Planned surgery during the trial
  • Unable to return for follow-up visits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

Loading map...

Research Team

G

Greg Lewis, MD

CONTACT

R

Rajeev Malhotra, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here