Status:
UNKNOWN
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Lead Sponsor:
China-Japan Friendship Hospital
Conditions:
Heart Failure With Reduced Ejection Fraction
Iron Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron defi...
Detailed Description
Acute heart failure (AHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting exercise capacity and quality of life. Previous comorbidities may account f...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) \<50% before randomization.
- 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.
- 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:
- Systolic blood pressure≥100mmHg, without symptoms of hypotension;
- Stop using intravenous diuretics;
- Neither intravenous inotropic drugs or vasodilators were used (including nitrates).
- Subject is iron deficient defined as serum ferritin \<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \<20%.
- Able and willing to provide informed consent and accomplish 6 minutes-walking test.
Exclusion
- Hematological criteria: ferritin \>400 ug/L; hemoglobin \<9.0, hemoglobin \>13.5 g/dL in women or \>14.5 g/dL in men.
- Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2
- Body weight \<35kg at randomization.
- Heart failure was secondary to valvular diseases or congenital heart diseases.
- History of acquired iron overload or hemochromatosis (or first-degree relative of hemochromatosis)
- 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)).
- Non-iron deficiency anaemia.
- Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.
- 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.
- 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).
- 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.
- 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.
- Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.
- Baseline 6 minutes-walking distance\>500m.
- Treated with long-term oral high-dose or steroid-immunosuppression therapy.
- Investigator considers a possible alternative diagnosis to explain the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD).
- Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
- Untreated hypothyroidism.
- Currently enrolled in any other investigational device or drug study \<30 days prior to screening, or received other investigational agent(s).
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT05971732
Start Date
August 1 2023
End Date
August 1 2025
Last Update
August 15 2023
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China