Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Clinically diagnosed with HF with infiltrates suggestive of pulmonary edema on chest x-ray. Rales noted on auscultation of the chest Oedema of more than or equal to one plus on a 0-3 plus scale, indicating skin indentation with mild digital pressure requiring 10 seconds or more to resolve in any dependent area including extremities or sacral region. Elevated jugular venous pressure (more than or equal to 8 cm H2O) Elevated natriuretic peptide levels, measured at first OPD contact or within less than or equal to 72 hours of the acute heart failure (AHF) admission must have been more than or equal to 1,600 pg per mL, or more than or equal to 2,400 pg per mL for subjects presenting with atrial fibrillation when the blood sample was taken. AHF episode treated with more than or equal to 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide) Subject has iron deficiency, defined as serum ferritin less than 100 ng per mL, or 100 299 ng per mL with transferrin saturation (TSAT) less than 20 percent. Must have provided written consent for the study.
Exclusion criteria
Exclusion criteria: Comorbid noncardiac conditions causing ID (e.g. hemorrhoids, solid organ or hematological malignancy, gastric ulcer, inflammatory bowel disease, pregnancy and other conditions causing chronic blood loss or iron malabsorptive states) Documented restricted amyloid myocardiopathy, or acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy Confounding assignment of etiology for fluid overload (e.g. end-stage renal failure) Clinical evidence of acute coronary syndrome, transient ischemic attack or stroke, within the last 30 days of recruitment Patients with specific etiologies (e.g. congenital heart disease) expected to follow a different natural history compared with a typical HF patient. Patients who had received intravenous iron within 3 months or on oral iron supplementation at presentation to hospital Acute HF due to accelerated hypertension, acute valve insufficiency, tachyarrhythmias, pulmonary embolism, or pericardial tamponade Severe valvular or left ventricular outflow obstruction disease needing intervention. Coronary-artery bypass graft, cardiac resynchronization therapy device implantation, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery that led to significant blood loss, including thoracic and cardiac surgery, within the last 3 months prior to recruitment. Subject has a body weight less than 35 kg Immediate need of transfusion or with a Hb less than 8g per dL or Hb greater than 15 g per dL. Subjects on treatment for Vitamin B12 and/or serum folate deficiency. Use of Vitamin B12 and folic acid as supplement therapy (not for deficiency treatment) is permitted. Known anaemia not attributed to ID (e.g. other microcytic anaemia) or with evidence of iron overload (e.g. haemochromatosis) or disturbances in the utilization of iron. Known hypersensitivity to parenteral iron
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive documentation of prevalence of ID, clinical outcomes and cardiac diagnostic indices in patients with HFrEF or HFpEF and concurrent ID over a period of two yearsTimepoint: Two years from study start date | — |
Secondary
| Measure | Time frame |
|---|---|
| Detailed analysis of both standard and advanced iron-related parameters [soluble transferrin receptor (sTfR), hepcidin levels] and cytokines (IL-1, IL-6, IL-18, GDF-15 and TNF-alpha) by applying standard biochemical techniques and study their association with symptoms, ECG, and ECHO parameters before and 6 months after iron repletion.Timepoint: Six months;To elucidate the role of iron in HF using mice models of ID and iron overload after 10 days or 28 days of iron deficient and iron overload diets.Timepoint: 10 and 28 days of onset of heart failure | — |
Countries
India
Contacts
Public ContactAditya John Binu
Christian Medical College, Vellore
Outcome results
None listed