Clinical trial • Phase IV • Cardiology
ferric carboxymaltose for Chronic heart failure | Iron deficiency
Phase IV trial of ferric carboxymaltose for Chronic heart failure | Iron deficiency.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Chronic heart failure | Iron deficiency
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule|Other
Key dates
- Initial CTIS Submission Date
- 26-11-2024
- First CTIS Authorization Date
- 21-01-2025
Trial design
Randomised, open-label, control group: ferric carboxymaltose (ferinject®) — dose between 500 and 2000 mg (depending on weight and hb values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible further administration of 500 mg at week 12 if persistent iron deficiency. sucrosomial iron group: sucrosomial iron (sideral forte®) 60 mg (2 tablets) once daily for 24 weeks. sucrosomial iron + vitamin d group: sucrosomial iron (sideral forte®) 60 mg (2 tablets) once daily + vitamin d3 (100000 iu loading dose with dibase® at time 0, then 2,000 iu daily with ultrad3®) for 24 weeks. Phase IV trial across 1 site in Italy.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Control group: Ferric carboxymaltose (Ferinject®) — dose between 500 and 2000 mg (depending on weight and Hb values), to be administered in 1 or 2 doses (time 0 ± 6 weeks) with possible further administration of 500 mg at week 12 if persistent iron deficiency. Sucrosomial iron group: Sucrosomial iron (SiderAl Forte®) 60 mg (2 tablets) once daily for 24 weeks. Sucrosomial iron + vitamin D group: Sucrosomial iron (SiderAl Forte®) 60 mg (2 tablets) once daily + Vitamin D3 (100000 IU loading dose with Dibase® at time 0, then 2,000 IU daily with UltraD3®) for 24 weeks.
- Target Sample Size
- 258
- Trial Duration For Participant
- 168
Stratification factors
- gender
- age
Eligibility
Recruits 258 Vulnerable population not selected; participants must be at least 18 years of age. A subject information and informed consent form is available (ICF_vers 1_5_11_11_24). No assent or minor-consent procedures are described..
- Pregnancy Exclusion
- pregnancy or breastfeeding;
- Vulnerable Population
- Vulnerable population not selected; participants must be at least 18 years of age. A subject information and informed consent form is available (ICF_vers 1_5_11_11_24). No assent or minor-consent procedures are described.
Inclusion criteria
- {"criterion_text":"- Stable symptomatic chronic heart failure (NYHA functional class II-III) and all of the following:\n- at least 3 weeks since the last hospitalization or emergency department access for acute HF\n- optimal drug treatment for heart failure (HF) according to the ESC guidelines determined by the investigator (unless contraindications or treatment not tolerated)\n- no changes in HF therapy dose in the previous 2 weeks (except diuretics)\n- no new HF therapy in the 3 weeks prior to recruitment\n- left ventricle ejection fraction <=45%\n- brain natriuretic peptide >100 pg/mL and/or N-terminal-pro-brain natriuretic peptide >400 pg/mL at pre-recruitment evaluation\n- evidence of iron deficiency defined as ferritin <100 ng/ml or TSAT <20% in the case of ferritin levels between 100 and 300 ng/ml\n- vitamin D levels <50 nmol/L\n- the subject must be able to complete the 6-Minute-Walking -Test\n- at least 18 years of age."}
Exclusion criteria
- {"criterion_text":"- Myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke, coronary artery bypass, percutaneous intervention, or major thoracic or cardiac surgery within the previous 2 months\n- clinically relevant (severe) non-corrected valvular heart disease, obstructive cardiomyopathy\n- chronic anemia due to non-correctable causes other than iron deficiency and anemia of chronic disease (e.g., hemoglobinopathies, hematologic malignancies, hemolytic anemia)\n- anemia due to vitamin B12 or acid folic deficiency (recruitment may be re-evaluated at least 6 weeks after the end of vitamin B12 and or folic acid supplementation)\n- history of acquired iron overload\n- administration of erythropoietin, iron supplementation (either oral or intravenous iron), blood transfusion in the previous 6 weeks or already scheduled for 3 months after recruitment\n- administration of vitamin D or similar in the 3 months preceding or already scheduled for the 3 months following recruitment\n- severe bone disease\n- active infections (C-reactive protein >20 mg/L)\n- clinically significant bleeding\n- active neoplasm (with exception of basal cell or squamous cell carcinoma of the skin and intraepithelial cervical neoplasia)\n- chronic liver disease (including active hepatitis) and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x normal limit\n- immunosuppressive therapy or dialysis\n- pregnancy or breastfeeding;\n- the subject has a known sensitivity to any of the products that will be administered during the study protocol."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The performance of the Six-Minute Walking Test (6MWT), comparing the mean difference from baseline of the distance walked by patients in meters.","definition_or_measurement_approach":"Comparison of mean difference from baseline in distance walked (meters) at 6MWT."}
Secondary endpoints
- {"endpoint_text":"- Assess in the tree-arms treatment during the study the change in Kansas City Cardiomyopathy Questionnaire(KCCQ) score, NYHA class, echocardiographic parameters (parameters of systolic and diastolic function, parietal thicknesses, and left ventricular diameters), calcium and phosphorus profile (levels of calcium, phosphate and human Fibroblast Growth Factors), incidence of fractures, glomerular filtration rate, surviving days out of hospital, hospitalizations and mortality","definition_or_measurement_approach":"Change from baseline in KCCQ score; change in NYHA class; changes in echocardiographic systolic/diastolic parameters and dimensions; measurement of calcium/phosphate and FGF levels; incidence counts for fractures, hospitalizations, surviving days out of hospital and mortality during follow-up."}
Recruitment
- Planned Sample Size
- 258
- Recruitment Window Months
- 32
- Consent Approach
- Informed consent obtained from adult participants (≥18). Subject information and informed consent form is available (ICF_vers 1_5_11_11_24). No assent or paediatric consent procedures described. Languages of consent not specified.
Methods
- Sequential recruitment of outpatients diagnosed with symptomatic chronic heart failure (NYHA II-III) and iron deficiency.
- Pre-randomization of inpatients hospitalized for acute HF episodes with re-evaluation for recruitment during an outpatient visit scheduled at least 3 weeks after stabilization.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 258
Italy
- Earliest CTIS Part Ii Submission Date
- 10-12-2024
- Latest Decision Or Authorization Date
- 21-01-2025
- Processing Time Days
- 42
- Number Of Sites
- 1
- Number Of Participants
- 258
Sites
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- DIMED
- Principal Investigator Name
- Federico Capone
- Principal Investigator Email
- federico.capone@unipd.it
- Contact Person Name
- Federico Capone
- Contact Person Email
- federico.capone@unipd.it
Sponsor
Primary sponsor
- Full Name
- Universita Degli Studi Di Padova
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Italy
Third parties
- {"country":"","full_name":"PharmaNutra Spa","duties_or_roles":"Source of monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Ferinject (ferric carboxymaltose)
- Active Substance
- ferric carboxymaltose
- Modality
- Other
- Routes Of Administration
- Intravenous injection/infusion
- Route
- Intravenous
- Authorisation Status
- Authorised (AIC 040251035)
- Starting Dose
- 500 mg (lower range of planned dose)
- Dose Levels
- 500-2000 mg depending on weight and Hb; possible further 500 mg at week 12 if persistent iron deficiency
- Frequency
- 1 or 2 doses at time 0 ±6 weeks; possible additional 500 mg at week 12
- Maximum Dose
- 2000 mg (with possible additional 500 mg at week 12; product maxTotalDose indicated as 2500 mg)
- Dose Escalation Increase
- Initial 500-2000 mg; possible additional 500 mg at week 12
- Investigational Product Name
- Sucrosomial iron (SiderAl Forte®)
- Modality
- Other
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Registered as nutritional supplement (Registro degli Integratori) / EAN listed
- Starting Dose
- 60 mg (2 tablets) once daily
- Dose Levels
- 60 mg once daily for 24 weeks
- Frequency
- Once daily
- Maximum Dose
- 60 mg daily
- Investigational Product Name
- Vitamin D3 (Dibase® 100000 U.I. then UltraD3® maintenance)
- Active Substance
- colecalciferol
- Modality
- Small molecule
- Routes Of Administration
- Intramuscular/injection (loading) and oral (maintenance)
- Route
- Loading: injection; Maintenance: oral
- Authorisation Status
- Authorised (AIC 036635023 for Dibase® injection)
- Starting Dose
- 100000 IU loading dose at time 0 (Dibase®), then 2,000 IU daily (UltraD3®)
- Dose Levels
- 100000 IU once (loading) then 2000 IU daily for 24 weeks
- Frequency
- Loading once at time 0; then daily maintenance (2000 IU)
- Maximum Dose
- 100000 IU single loading dose; 2000 IU daily maintenance
- Investigational Product Name
- UltraD3® (maintenance vitamin D3 preparation)
- Active Substance
- colecalciferol
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Registered (vitamin supplement listing/EAN)
- Starting Dose
- 2000 IU daily
- Dose Levels
- 2000 IU daily for 24 weeks
- Frequency
- Once daily
- Maximum Dose
- 2000 IU daily
- Combination Treatment
- Yes
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