Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-29 @ 7:40 PM
Study NCT ID:
NCT05991128
Status:
UNKNOWN
Last Update Posted:
2023-09-26
First Post:
2023-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718030', 'term': 'ferric derisomaltose'}, {'id': 'D007501', 'term': 'Iron'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-25', 'studyFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2023-08-03', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR)', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'Urine Albumin-to-Creatinine Ratio (UACR) is regard as a safety endpoint to reflect early injury of kidney.'}, {'measure': 'A rise of high-sensitivity C-reaction protein (hs-CRP) levels from baseline', 'timeFrame': 'Up to 4 weeks', 'description': 'Safety endpoint is defined as a elevation of high-sensitivity C-reaction protein (hs-CRP) from baseline up to 4 weeks'}, {'measure': 'Adverse Event after IV iron injection', 'timeFrame': 'Up to 4 weeks', 'description': 'Adverse Event Include Fishbane symptoms (flushing/chest pain/back pain/chest tightness, sometimes with dyspnea), isolated signs and symptoms (urticaria/pruritus/rash/mild hypotension, hypertension/tachycardia/nausea/headache), signs and symptoms of allergic reactions (persistent hypotension; airway angioedema/generalized urticaria, non-airway angioedema/wheezing, bronchospasm, vomiting, abdominal pain, etc.'}], 'primaryOutcomes': [{'measure': 'Change in 6-minute walking distance', 'timeFrame': 'Up to 3 days', 'description': 'The difference of 6-minute walking distance in meters from baseline to day3 after IV iron injection.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 6-minute walking distance', 'timeFrame': 'At 2 weeks, 4weeks after IV iron injection', 'description': 'The difference of 6-minute walking distance in meters from baseline at 2 weeks, 4weeks after IV iron injection.'}, {'measure': 'Change From Baseline in the KCCQ Clinical Summary Score', 'timeFrame': 'At 2 weeks, 4weeks after IV iron injection', 'description': "KCCQ was a 23-item, self-administered questionnaire that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), quality of life (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status. KCCQ-clinical summary score was average of domains- physical limitation and total symptoms (average of symptom frequency and symptom burden), and transformed to a single score which ranged from 0 (worst) -100 (the best possible status), where the higher score reflected better health status."}, {'measure': 'Change From Baseline in the EQ-5D-5L Questionnaire Indexed Value', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration.\n\nThe descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).'}, {'measure': 'Change From Baseline in NYHA Functional Class', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'NYHA = New York Heart Association\n\nNYHA functional class was assessed as Class I, II, III, IV:\n\nClass I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.\n\nClass II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.\n\nClass III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest.\n\nClass IV - Severe limitations. Experiences symptoms even while at rest. Lower response categories are better for score NYHA.'}, {'measure': 'Change From Baseline in PGA quality of life questionnaire', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'PGA:Patient Global Assessment\n\nPGA questionnaire consists of a health descriptive system for participants to self-reported and rate their medical condition after participate this study.\n\nThe descriptive system includes 7 choices：has much improved, has (moderately) improved, has a little improved, is unchanged, is a little worse, is (moderately) worse, is much worse, which are coded from 1 (best state) to 7 (worst state).'}, {'measure': 'Change From Baseline in Concentration of hemoglobin (Hb)', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'Hemoglobin (Hb) is a commonly used clinical test for assessing anaemia, with units of g/L.'}, {'measure': 'Change From Baseline in proportion of reticulocyte (Ret%)', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'The reticulocyte ratio is often used to reflect the hematopoiesis of the bone marrow erythrocyte with units of percentage(%).'}, {'measure': 'Change From Baseline in Concentration of ferritin', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'To assess the effect of ferric derisomaltose vs. placebo on change in ferritin from baseline to 3 days, 2weeks and 4weeks'}, {'measure': 'Change From Baseline in Concentration of transferrin saturation', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'To assess the effect of ferric derisomaltose vs. placebo on change in transferrin saturation from baseline to 3 days, 2weeks and 4weeks'}, {'measure': 'Change From Baseline in Concentration of serum transferrin receptors (sTfR)', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'To assess the effect of ferric derisomaltose vs. placebo on change in serum transferrin receptors (sTfR) from baseline to 3 days, 2weeks and 4weeks'}, {'measure': 'Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'At 3 days, 2weeks, 4weeks after IV iron injection', 'description': 'To assess the effect of ferric derisomaltose vs. placebo on change in NT-proBNP from baseline to 3 days, 2weeks and 4weeks'}, {'measure': 'Change From Baseline in Left Ventricular Diastolic Function', 'timeFrame': 'At 2weeks, 4weeks after IV iron injection', 'description': "Indicators of diastolic function including E/A、E、E/e' are assessed by two-dimensional directed pulse-doppler echocardiography."}, {'measure': 'Change From Baseline in Left Atrial Diameter', 'timeFrame': 'At 2weeks, 4weeks after IV iron injection', 'description': 'Left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise capacity', 'Quality of life', 'Acute Heart Failure'], 'conditions': ['Heart Failure With Preserved Ejection Fraction', 'Iron Deficiencies', 'Acute Heart Failure']}, 'descriptionModule': {'briefSummary': '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 deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.', 'detailedDescription': 'Acute heart failure is very common medical problem. Despite many clinical trials conducted to date in these patients, the rates of adverse outcomes remain very high. Previous comorbidities may account for it. Approximately 80% of patients hospitalized with AHF suffered from a combination of iron deficiency. A decline in exercise capacity may occur under this condition. Some research studies have suggested that giving CHF patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with AHF to improve excise capacity and whether it improves quality of life and accelerate recovery from acute duration. This study will help us answer these key questions.\n\nThis is an investigator-initiated, randomised, parallel group, double-blind, placebo-controlled trial, evaluating the excise capacity improvement of using ferric derimaltose versus placebo in hospitalized patients with acute heart failure with preserved ejection fraction before discharge.\n\nParticipants will be assessed daily using 6-minute walking test after IV iron injection until discharge from hospital, especially focus on the change from baseline to the 3rd day. Some questionnaire are also conducted to evaluate the self-reported status. Participants will be followed up at 2 weeks and 4 weeks.\n\nThe primary and secondary endpoints will be examined in subgroups predefined by baseline variables reflecting demography, Hb level, etiology of HF, left ventricular ejection fraction, natriuretic peptide, index of iron metabolism, eGFR and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) ≥50% before randomization.\n3. 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\n4. 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:\n\n 1. Systolic blood pressure≥100mmHg, without symptoms of hypotension;\n 2. Stop using intravenous diuretics;\n 3. Neither intravenous inotropic drugs or vasodilators were used (including nitrates).\n5. Subject is iron deficient defined as serum ferritin \\<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \\<20%.\n6. Able and willing to provide informed consent and accomplish 6 minutes-walking test.\n\nExclusion Criteria:\n\n1. Haematological criteria: ferritin \\>400ug/L; haemoglobin \\<9.0 g/dL, or \\>13.5 g/dL (for female), 14.5g/dL (for male).\n2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \\<15ml/min/1.73m2\n3. Body weight\\<35kg at randomization.\n4. Heart failure was secondary to valvular diseases or congenital heart diseases.\n5. History of acquired iron overload or hemochromatosis (or first-degree relative of haemochromatosis)\n6. 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)).\n7. Non-iron deficiency anaemia.\n8. Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.\n9. 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.\n10. 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).\n11. 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.\n12. 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.\n13. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.\n\n14.6 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).\n\n17.Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.\n\n18.Untreated hypothyroidism. 19.Currently enrolled in any other investigational device or drug study \\<30 days prior to screening or received other investigational agent(s)."}, 'identificationModule': {'nctId': 'NCT05991128', 'acronym': 'COREVIVE-HFpEF', 'briefTitle': 'The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'China-Japan Friendship Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'Monofer-HFpEF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferric derisomaltose', 'description': "Iron to be administered as ferric derisomaltose.\n\nThe treatment dose (mL) to be administered will be determined by the patient's body weight and haemoglobin (Hb) value.\n\nWhere Hb ≥10 g/dL, dosage according to body weight is as follows:\n\nBody weight \\<50 kg: 20 mg/kg; Body weight 50 to \\<70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg.\n\nWhere Hb \\<10 g/dL, dosage according to body weight is as follows:\n\nBody weight \\<50 kg: 20 mg/kg; Body weight 50 to \\<70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg.\n\nInfused over a minimum of 15mins for doses up to and including 1000mg, and a minimum of 30 mins for doses \\>1000mg", 'interventionNames': ['Drug: Ferric derisomaltose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants in this arm will receive normal saline 0.9% in analogy to treatment arm.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ferric derisomaltose', 'type': 'DRUG', 'otherNames': ['Monofer', 'Iron (III) isomaltoside 1000'], 'description': 'After baseline assessments patients will be randomised in a 1:1 ratio to receive ferric derisomaltose IV or placebo (normal saline). In the Treatment group, Ferric derisomaltose will be administered according to the dosing schedule.', 'armGroupLabels': ['Ferric derisomaltose']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal saline'], 'description': 'n the placebo group, patients will receive the equivalent number of normal saline injections.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Chaoyang District', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Zhou, Dr', 'role': 'CONTACT', 'email': '929352903@qq.com', 'phone': '+86-13699164283'}], 'facility': 'China-Japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Ying Zhou, Dr', 'role': 'CONTACT', 'email': '929352903@qq.com', 'phone': '+86-13699164283'}, {'name': 'Peizhao Li, Dr', 'role': 'CONTACT', 'email': 'lipz7014@163.com', 'phone': '+86-18443151740'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jingyi Ren', 'investigatorAffiliation': 'China-Japan Friendship Hospital'}}}}