TerminatedPhase 4

Effects of IV Iron Replacement on Exercise Capacity in Individuals With Heart Failure

Stopped: Difficulty with accrual.

United States6 participantsStarted 2024-01-24

Plain-language summary

Patients with heart failure with reduced ejection fraction and iron deficiency will be randomized to either receive iron infusion or be in the control group. The study is looking at how iron replacement affects exercise capacity as measured by peak oxygen uptake.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-90 years * New York Heart Association Class II-III heart failure * Left ventricular dysfunction with left ventricular ejection fraction ≤ 40% * Ferritin \< 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) \< 20% * Patients deemed by an attending physician to require intravenous iron therapy * The patient is willing and able to comply with the protocol and has provided written informed consent Exclusion Criteria: * Iron overload disorders or allergy, concomitant nutritional deficiencies- B12 and folate * Recent Acute Coronary Syndrome * Physical barriers to exercise capacity * Currently presenting in heart failure exacerbation * Declined participation * Chronic liver disease * NYHA class IV * Active bleeding * Pregnancy * Life expectancy ≤ 12 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exercise Capacity

Timeframe: 2 months after IV iron infusion

Patient subjective outcome measures

Timeframe: 2 months after IV iron infusion

Trial details

NCT IDNCT05816265

SponsorRadha Gopalan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-18

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.