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

ConditionsHeart FailureIron Deficiency
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years.

Left ventricular ejection fraction (LVEF) <50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).

New York Heart Association (NYHA) class II ~ III.

Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP >300 pg/mL or BNP >100 pg/mL. b. For patients in atrial fibrillation: NT-proBNP >600 pg/mL or BNP >200 pg/mL.

Disqualifiers

Hemoglobin <9.0 g/dL or Hemoglobin >15.0 g/dL.

Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2.

Body weight <35 kg.

Heart failure was secondary to valvular diseases or congenital heart diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-dose ferric derisomaltose

    Drug

    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.

  • Low-dose ferric derisomaltose

    Drug

    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.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: High doseExperimental treatment 1 intervention
Group B: Low doseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in peak VO2 (ml/min/kg）

Peak VO2 measured by a maximal effort Cardiopulmonary Exercise Test (CPET)

Time frame
Baseline to Week 52

Secondary outcomes

1

Change in VO2 at ventilatory threshold (ml/min）

Measured by CPET

Time frame
Baseline to Week 52
2

Change in heart rate at peak exercise (bpm)

Measured by CPET

Time frame
Baseline to Week 52
3

Change in peak respiratory exchange ratio

Measured by CPET

Time frame
Baseline to Week 52
4

Change in 6-minute walking distance (m)

Time frame
Baseline to Week 26 and Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Source ClinicalTrials.gov
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