RecruitingPhase 4NCT06427343

The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency

The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)


Sponsor

China-Japan Friendship Hospital

Enrollment

114 participants

Start Date

Oct 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a low dose or high dose of IV iron (given through a vein) works better for people who have chronic heart failure and low iron levels. Researchers want to see which amount improves exercise ability and heart function more. **You may be eligible if...** - You are over 18 years old - You have heart failure with reduced pumping function (heart pumps less than 50% of normal) - Your symptoms are moderate — you feel breathless or tired with everyday activities but not at rest - You were hospitalized for heart failure in the past 6 months OR have had abnormal heart-related blood tests recently - Your heart failure has been stable for at least 4 weeks on your current medications - Your iron levels are low (low ferritin or low iron saturation in the blood) - You are able to do a supervised exercise breathing test **You may NOT be eligible if...** - Your blood count (hemoglobin) is very low or very high - You are on kidney dialysis or have severe kidney disease - You weigh less than 35 kg - Your heart failure was caused by a leaky or narrowed valve, or a birth defect of the heart - You have a known iron storage disease (like hemochromatosis) or a family member has it - You are allergic to IV iron products - You have an active infection, active bleeding, cancer, or a blood disorder - You had a heart attack or stroke in the past 3 months - You are pregnant or breastfeeding - You have been on IV or oral iron therapy in the last 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHigh-dose ferric derisomaltose

After baseline assessment, participants will be randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during follow-up. In the high-dose group, participants will receive repeat iron dosing as long as the serum ferritin was not \>700 ng/mL, or if TSAT was not \>40% during follow-up.

DRUGLow-dose ferric derisomaltose

In the low-dose group, participants will receive repeat iron dosing if ferritin \<100 ng/mL or if ferritin 100-300 ng/mL and TSAT \>20% during follow-up.


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT06427343


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