Chronic heart failure
Conditions
Interventions
Product Name: UltraD3
Product Code: [UltraD3]
Pharmaceutical Form:
INN or Proposed INN: Vitamina D
CAS Number: 67-97-0
Current Sponsor code: 002_D
Concentration unit: µg microgram(s)
Concentration ty
Sponsors
Dipartimento di Medicina-DIMED, università di Padova
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Stable symptomatic chronic heart failure (NYHA functional class II-III) and all of the following: - At least 3 weeks since the last hospitalization or emergency department access for acute HF. - Optimal drug treatment for heart failure (HF) according to the ESC guidelines2 determined by the investigator (unless contraindications or treatment not tolerated). - No changes in HF therapy dose in the previous 2 weeks (except diuretics). - No new HF therapy in the 3 weeks prior to recruitment. - Left ventricle ejection fraction =45% - Brain natriuretic peptide >100 pg/mL and/or N-terminal-pro-brain natriuretic peptide >400 pg/mL at pre-recruitment evaluation. - Evidence of iron deficiency defined as ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 158
Exclusion criteria
Exclusion criteria: -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. - Clinically relevant (severe) non-corrected valvular heart disease, obstructive cardiomyopathy. - Chronic anemia due to non-correctable causes other than iron deficiency and anemia of chronic disease (e.g., hemoglobinopathies, hematologic malignancies, hemolytic anemia). - 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. - History of acquired iron overload. - 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. - Administration of vitamin D or similar in the 3 months preceding or already scheduled for the 3 months following recruitment. - Severe bone disease. - Active infections, C-reactive protein >20 mg/L, clinically significant bleeding, active neoplasm (with exception of basal cell or squamous cell carcinoma of the skin and intraepithelial cervical neoplasia). - Chronic liver disease (including active hepatitis) and/or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x normal limit. - Immunosuppressive therapy or dialysis. - Pregnancy or breastfeeding. - The subject has a known sensitivity to any of the products that will be administered during the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate whether, in patients with chronic heart failure and iron deficiency, the administration of vitamin D in combination with sucrosomial iron is as effective as intravenous ferric carboxymaltose in improving symptoms of heart failure. The first aim is to test the non-inferiority of sucrosomial iron treatment compared with the ferric carboxymaltose treatment, after 24 weeks of treatment.;Secondary Objective: -Assess quality of life (QoL), physical limitations, symptoms, and limitations in social life (QoL Endpoints) - Assess the impact of vitamin D supplementation combined with sucrosomial iron on New York Heart Association (NYHA) class, relevant laboratory and echocardiographic parameters, re-hospitalizations, and mortality in patients with HF and ID (Cardiovascular Endpoints and General Endpoints) - Assess the effects of iron supplementation (either intravenous, oral, or with the addition of vitamin D) on calcium-phosphorus metabolism (Calcium-phosphorus metabolism Endpoints);Primary end point(s): The performance of the Six-Minute Walking Test (6MWT), comparing the mean difference from baseline of the distance walked by patients in meters.;Timepoint(s) of evaluation of this end point: This endpoint is evaluating during the outpatient visits at 6-12-24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assess the change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score in the tree-arms treatment during the study; Cardiovascular Endpoints and general endpoints: - Change from baseline in the NYHA class in the sucrosomial iron + vitamin D group compared to the control group after 12 and 24 weeks. - Change from baseline in the NYHA class in the sucrosomial iron + vitamin D group compared to the sucrosomial iron group after 12 and 24 weeks. - Change from baseline in the distance walked at 6-minute-walking-test in the sucrosomial iron + vitamin D group compared to the sucrosomial iron alone after 12 and 24 weeks - Change in glomerular filtration rate estimated using the CKD-EPI formula - Surviving days out of hospital. - Hospitalizations (total, cardiovascular, due to Heart failure). - Mortality (total, cardiovascular, due to Heart failure); -Assess the changes in echocardiographic parameters (LVEF, [Simpson's method], left ventricle end diastolic diameter [LVEDD] and left ventricle end systolic diameter [LVESD], left ventricle end diastolic volume [LVEDV], left ventricle end systolic volume [LVESV] Interventricular septal thickness [IVS] and left ventricular posterior wall [PW], diastolic function parameters [E/A ratio, E/e'], left atrial volume index [LAVI], Tricuspid regurgitation [TR] peak velocity) compared with baseline in the sucrosomial iron + vitamin D group after 24 weeks. -Assess the changes in echocardiographic parameters (LVEF, LVEDD, LVESD, LVEDV, LVESV, IVS, PW, E/A ratio, E/e', LAVI, TR peak velocity) in the sucrosomial iron + vitamin D group compared with the control group after 24 weeks.; -Assess the plasma levels of calcium, phosphate, and human Fibroblast Growth Factors-23 (FGF-23) in the sucrosomial iron + vitamin D group compared to the control group after 12 and 24 weeks of treatment. - Assess the plasma levels of calcium, phosphate and FGF-23 in the sucrosomial iron group compared to the control group after 12 | — |
Countries
Italy
Contacts
Public ContactUfficio Ricerca e Terza Missione
Dipartimento di Medicina - UNIPD
Outcome results
None listed