IRONICA: IRON Repletion in Congestive Heart Failure - A Randomized Controlled Trial Comparing Oral Versus IV Approaches
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in 6-Minute Walk Distance
研究概览
简要总结
The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent.
The main questions the study will answer are:
- Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks?
- Does IV iron improve symptoms and quality of life more than oral iron?
- How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality?
Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better.
What participants will do
- Be randomly assigned by (like flipping a coin) to IV iron or oral iron.
- Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks.
- Visit the infusion clinic at 6 weeks for second dose of IV iron if needed.
- Visit the clinic at 12 weeks for a follow-up to gather follow-up data including
- A 6-minute walk test
- Brief symptom and quality-of-life surveys
- Blood tests to measure serum iron, ferritin, and transferrin saturation
This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Investigators and participants know group assignment. 6-minute walk test staff, data analysts, and clinical endpoint adjudicators remain blinded.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •BMI ≥18.0 kg/m²
- •Hemoglobin:
- •> 9 g/dL and <14 g/dL for men > 9 g/dL and <13 g/dL for women
- •Diagnosed with Congestive Heart failure:
- •HFrEF: EF ≤40% in any recent echocardiogram HFpEF: EF ≥50-55% without any prior EF ≤40%, and evidence of diastolic dysfunction per ASE/EACVI 2023 criteria-defined as either grade ≥2 or ≥2 supporting echo parameters (septal e' <7 cm/sec or lateral e' <10 cm/sec, E/e' ≥15, TR velocity >2.8 m/s, LA volume index ≥34 mL/m², LV septal or posterior wall thickness ≥1.2 cm, or LA area ≥20 cm² / diameter ≥3.8 cm.
- •Documented elevated NT-proBNP based on BMI and rhythm:
- •BMI <35: ≥220 pg/mL (NSR) or ≥660 pg/mL (A-Fib) BMI ≥35: ≥125 pg/mL (NSR) or ≥375 pg/mL (A-Fib)
- •NYHA Class II-IV
- •Transferrin saturation (TSAT) <20%
- •Hemoglobin <14 g/dL for men, < 13 g/dL for women.
- •Stable on heart failure therapy for ≥2-4 weeks
- •Currently prescribed a diuretic at home
- •Ambulatory (able to walk >20 ft with minimal assistance)
- •Willing and able to give informed consent
排除标准
- •Received IV iron, ESA, or blood transfusion within the last 6-12 months
- •Received high-dose oral iron (>100 mg/day in past 7 days)
- •Severe renal impairment (eGFR <15 mL/min/1.73 m² or on dialysis)
- •Patients with known cirrhosis or transaminitis with AST >141 or ALT >112 IU/L
- •Active bleeding or known bleeding disorder
- •Recent cardiac surgery, myocardial infarction, or stroke within past 3 months
- •Active infection, defined as any systemic or deep-seated infection (e.g., bacteremia, sepsis, osteomyelitis, or infections requiring IV antibiotics or hospitalization) at the time of screening.
- •Active malignancy or undergoing chemotherapy/radiotherapy
- •Vitamin B12 or folate deficiency (unless corrected prior to enrollment)
- •Chronic liver disease (with LFTs >3× upper limit of normal)
- •Pregnant or breastfeeding women or those not using effective contraception
- •Lacks capacity to consent or unable to comply with study procedures
研究组 & 干预措施
IV Iron (Ferric Carboxymaltose)
Patients randomized to receive intravenous ferric carboxymaltose. Dosing includes a 1-gram IV infusion during the index hospital stay, followed by a second infusion at Week 6 (1,000 mg if > 70 kg or 500 mg if ≤ 70 kg).
干预措施: Ferric Carboxymaltose (Drug)
Oral Iron (Ferrous Sulfate)
Patients randomized to receive one capsule of oral ferrous sulfate (Ferrex 150 mg) every 48 hours for 12 weeks.
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
Change in 6-Minute Walk Distance
时间窗: Baseline and 12 weeks
Change in distance (in meters) walked during the 6-minute walk test from baseline to 12 weeks.
Change in 6-Minute Walk Distance
时间窗: Baseline and 12 weeks
Change in distance (in meters) walked during the 6-minute walk test from baseline to 12 weeks.
次要结局
- Change in NYHA Functional Class(Baseline and 12 weeks)
- Change in Quality of Life(Baseline and 12 weeks)
- Heart Failure Readmissions(Through 12 weeks)
- Change in Iron Stores(Baseline and 12 weeks)
- All-Cause Mortality(Through 12 weeks)
- Major Adverse Cardiac Events (MACE)(Through 12 weeks)
- Adverse Events Related to Study Drug(Through 12 weeks)
- Change in NYHA Functional Class(Baseline and 12 weeks)
- Change in Quality of Life(Baseline and 12 weeks)
- Change in Iron Stores(Baseline and 12 weeks)
- All-Cause Mortality(Through 12 weeks)
- Heart Failure Readmissions(Through 12 weeks)
- Major Adverse Cardiac Events (MACE)(Through 12 weeks)
- Adverse Events Related to Study Drug(Through 12 weeks)
研究者
Syed Hamza Mufarrih
Principal Investigator
Western Kentucky Heart and Lung Research Foundation and Educational Trust