Effects of Ferric Derisomaltose on Exercise Capacity and Quality of Life in Heart Failure Patients

The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life: a Randomised, Parallel-group, Double-blind, Placebo Controlled Trial (COREVIVE-HFrEF)

This study is testing if adding Ferric Derisomaltose to regular treatment can help people with heart failure and low iron feel better and exercise more easily.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05971732 on ClinicalTrials.gov

What this trial studies

This study evaluates whether adding Ferric Derisomaltose to standard care improves exercise capacity and quality of life in patients with acute heart failure and iron deficiency. Participants will be randomly assigned to receive either Ferric Derisomaltose or a placebo (normal saline) while hospitalized. The primary assessment will involve a 6-minute walking test conducted daily until discharge, with additional follow-ups at 2 and 4 weeks post-discharge. The study aims to determine the impact of correcting iron deficiency on recovery and overall well-being in this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of heart failure with reduced ejection fraction who are hospitalized for acute heart failure and are iron deficient.

Not a fit: Patients who do not have iron deficiency or those with heart failure not classified as reduced ejection fraction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly enhance exercise capacity and quality of life for patients suffering from acute heart failure and iron deficiency.

How similar studies have performed: Previous studies have suggested that intravenous iron may improve symptoms in chronic heart failure patients, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years.
2. Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) \<50% before randomization.
3. Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV.
4. Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:

   1. Systolic blood pressure≥100mmHg, without symptoms of hypotension;
   2. Stop using intravenous diuretics;
   3. Neither intravenous inotropic drugs or vasodilators were used (including nitrates).
5. Subject is iron deficient defined as serum ferritin \<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \<20%.
6. Able and willing to provide informed consent and accomplish 6 minutes-walking test.

Exclusion Criteria:

1. Hematological criteria: ferritin \>400 ug/L; hemoglobin \<9.0, hemoglobin \>13.5 g/dL in women or \>14.5 g/dL in men.
2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2
3. Body weight \<35kg at randomization.
4. Heart failure was secondary to valvular diseases or congenital heart diseases.
5. History of acquired iron overload or hemochromatosis (or first-degree relative of hemochromatosis)
6. Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)).
7. Non-iron deficiency anaemia.
8. Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.
9. Active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal haemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease) and history of malignant tumor.
10. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate\> 100 beats / min at rest).
11. Known positive HBsAg and/or HCV RNA; known HIV positivity; chronic liver disease (including active hepatitis), hepatic sclerosis, ALT or AST \> 3x upper limit of normal.
12. Within 3 months of any of the following: acute myocardial infarction (AMI) or acute coronary syndrome (ACS), transient ischemic attack (TIA) or stroke, uncontrolled hypertension.
13. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.
14. Baseline 6 minutes-walking distance\>500m.
15. Treated with long-term oral high-dose or steroid-immunosuppression therapy.
16. Investigator considers a possible alternative diagnosis to explain the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD).
17. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
18. Untreated hypothyroidism.
19. Currently enrolled in any other investigational device or drug study \<30 days prior to screening, or received other investigational agent(s).

Where this trial is running

Beijing, Beijing

• China-Japan Friendship Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: Ying Zhou, Dr

Conditions Heart Failure With Reduced Ejection Fraction; Iron Deficiency; Acute Heart Failure; Exercise capacity; Quality of life