Effects of Intravenous Iron Therapy With Ferric Carboxymaltose Compared With Oral Iron Therapy in Heart Failure With Preserved Ejection Fraction and Iron Deficiency (PREFER-HF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Six minute walking test distance
研究概览
简要总结
The purpose of the study is to evaluate whether the administration of iron to patients with heart failure and preserved ejection fraction results in an improvement of symptoms and functional class, in addition to evaluating whether oral iron is equivalent to intravenous iron to achieve this improvement.
详细描述
Iron deficiency is one of the most prevalent co-morbid conditions in chronic heart failure. In the absence of any iron treatment, it is estimated that up to 50% of patients with heart failure have low levels of available iron. Treatment with intravenous iron improves exercise tolerance , quality of life , and reduces hospitalization in patients with chronic heart failure and reduced ejection fraction. However data on the effect of iron therapy in patients with heart failure with preserved ejection fraction are still lacking. The evidence related to oral iron therapy in HF is limited and no randomized trials compared oral iron vs no iron therapy in the absence of erythropoiesis-stimulating agents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with stable chronic HF (NYHA II/IV functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics). In general, optimal pharmacological treatment should include an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a beta blocker unless contraindicated or not tolerated and diuretic if indicated.
- •Left ventricular ejection fraction >45% (value within 3 months of planned date of randomization).
- •BNP >100 pg/mL and/or N-terminal-pro-BNP >400 pg/mL at the screening visit.
- •Subject must be capable of completing the 6 minute walking test
- •Screening serum ferritin <100 ng/mL or 100-300 ng/mL with transferrin saturation <20%.
- •At least 18 years of age.
- •Before any study-specific procedure, the appropriate written informed consent must be obtained.
排除标准
- •Subject has known sensitivity to any of the products to be administered during dosing.
- •History of acquired iron overload.
- •History of erythropoietin-stimulating agent, i.v. iron therapy, and/or blood transfusion in previous 6 weeks prior torandomization.
- •Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. Note: ongoing use of multivitamins containing iron <75 mg/day is permitted.
- •Exercise training programme(s) in the 3 months prior to screening or planned in the next 6 months.
- •Known active bacterial infection.
- •Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.
- •Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity.
- •Vitamin B12 and/or serum folate deficiency. If deficiency-corrected subject may be rescreened for inclusion.
- •Subjects with known seropositivity to human immunodeficiency virus.
- •Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.
- •Currently receiving systemic chemotherapy and/or radiotherapy.
- •Renal dialysis (previous, current, or planned within the next 6 months).
- •Unstable angina pectoris as judged by the investigator; severe valvular or left ventricular outflow obstruction disease needing intervention; atrial fibrillation/flutter with a mean ventricular response rate at rest >100 beats per minute.
- •Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
- •Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
- •Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(ies), or subject is receiving other investigational agent(s).
- •Subject of childbearing potential who is pregnant (e.g. positive human chorionic gonadotropin test) or is breastfeeding.
- •Subject will not be available for all protocol-specified assessments.
- •Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
研究组 & 干预措施
Placebo
normal saline solution plus oral lactose capsules
干预措施: Placebo (Other)
Intravenous ferric carboxymaltose
Ferric carboxymaltose 500-1000 mg at 0,6,12,24 weeks ( adjusted by protocol)
干预措施: Ferric carboxymaltose (Drug)
Oral iron A: ferroglycine sulfate
oral capsules of ferroglycine sulfate iron until week 24
干预措施: Ferroglycine Sulfate (Drug)
Oral iron B: sucrosomial iron
oral capsules of sucrosomial iron until week 24
干预措施: Sucrosomial Iron (Drug)
结局指标
主要结局
Six minute walking test distance
时间窗: 24 weeks
Change in meters traveled in six minute walking test from baseline to week 24. An increase in distance is related to an improvement in functional capacity.
次要结局
- Change in New York Heart Association (NYHA) functional classification(24 weeks)
- Hospitalizations(24 weeks)
- Quality of Life assesed by Kansas City Cardiomyopathy Questionnaire(24 weeks)
- Mortality(24 weeks)
研究者
José Luis Morales Rull, MD, PhD
José Luis Morales Rull, MD, PhD, Principal Investigator NUTRIMMIC group ( Nutrition Metabolism and Microbiota in Heart Failure)
Institut de Recerca Biomèdica de Lleida