To study Effect of injectable iron for improving quality of life and mortality in patients with heart failure with reduced ejection fraction with iron deficiency.
- Conditions
- Health Condition 1: I501- Left ventricular failure, unspecified
- Registration Number
- CTRI/2022/06/043440
- Lead Sponsor
- PGIMER CHANDIGARH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Age � 18 years.
Patients with LVEF <45% with NYHA class II-III without anemia (defined as Hemoglobin <12 in females and <13 in males)(41).
Iron deficiency, defined as either serum ferritin <100 �¼g/L or 100-299�¼g/L with TSAT < 20%.
Patients who give consent.
Any clinically overt bleeding (gastrointestinal bleeding, hypermenorrhoea, history of peptic ulcer without evidence of healing or inflammatory intestinal diseases).
Any inflammatory, neoplastic or infectious disease.
Recent myocardial revascularization procedures.
Active or metastatic neoplastic disease.
Age �18 years.
Patients/patientââ?¬•s attender who refuse to give consent.
Unknown patients.
Any contraindications to IV iron therapy
Anemia not attributable to iron deficiency.
Iron overload.
Prior hypersensitivity reactions to intravenous iron therapy.
Acute or chronic infection.
Pregnancy- 1st trimester.
Acute Kidney Injury.
Patients with a history of severe asthma, eczema or other atopic allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in 6-min-walk-test (6MWT) distance from baseline to Week four after IV iron therapy.Timepoint: Change in 6-min-walk-test (6MWT) distance from baseline to Week four after IV iron therapy.
- Secondary Outcome Measures
Name Time Method 🠶 Improvement in New York Heart Association class at 4 weeks. <br/ ><br>🠶 Rate of HF-related or other cardiovascular hospitalizations at 12 weeks. <br/ ><br>🠶 Time to death for any reason by 12 weeks. <br/ ><br>Timepoint: 12 weeks