Effects of Ferric Derisomaltose on Exercise 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-HFpEF)

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: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Chaoyang District)
• Trial ID: NCT05991128 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether adding Ferric Derisomaltose to standard care can enhance exercise capacity and quality of life for patients suffering from acute heart failure and iron deficiency. Participants will be randomly assigned to receive either Ferric Derisomaltose or a placebo (normal saline) while hospitalized. The study will assess changes in exercise capacity using a 6-minute walking test and self-reported questionnaires during their hospital stay and follow-ups at two and four weeks post-discharge. The aim is to determine if correcting iron deficiency can lead to significant improvements in patient outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are hospitalized for acute heart failure with preserved ejection fraction and have documented iron deficiency.

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

Why it matters

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

How similar studies have performed: Previous studies have suggested that intravenous iron can 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 preserved ejection fraction (HFpEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) ≥50% before randomization.
3. Currently hospitalized for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalization, New York Heart Association (NYHA) class II - IV.N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP≥600 or BNP ≥200 pg/mL in atrial fibrillation prior to randomization
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. Haematological criteria: ferritin \>400ug/L; haemoglobin \<9.0 g/dL, or \>13.5 g/dL (for female), 14.5g/dL (for male).
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 haemochromatosis)
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 heart 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.

14.6 minutes-walking distance\>500m at baseline. 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, Chaoyang District

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

Study contacts

• Study coordinator: Ying Zhou, Dr

Conditions Heart Failure With Preserved Ejection Fraction; Iron Deficiencies; Acute Heart Failure; Exercise capacity; Quality of life