Ferric Carboxymaltose to Improve Skeletal Muscle Metabolism in Heart Failure Patients With Functional Iron Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change From Baseline in Post-Exercise Phosphocreatine Recovery Time
研究概览
简要总结
The purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (HF).
Heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. Patients with heart failure may feel shortness of breath or leg fatigue when they exercise. Iron is an essential nutrient in the diet. In heart failure patients, low body levels of iron might increase shortness of breath and fatigue.
详细描述
The purpose of this prospective, double blind parallel group randomized study is to compare the effects of ferric carboxymaltose vs. placebo on skeletal muscle mitochondrial oxidative capacity, submaximal exercise tolerance, and health-related quality of life in non-anemic Heart Failure (HF) patients with functional iron deficiency.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic NYHA Class II-III heart failure >3 months
- •Guideline-recommended heart failure treatment for > 3 months
- •Hemoglobin >13 g/dl for men and >12 g/dl for women
- •Functional iron deficiency (defined as serum ferritin level <100 ng/ml or between 100 and 299 ng/ml with transferrin saturation <20%)
- •Left ventricular ejection fraction <40%, or left ventricular ejection fraction ≥40% with left atrial enlargement (left atrial volume index >28 ml/m2) and/or left ventricular hypertrophy (left ventricular mass index >95 g/m2 (women) or >115 g/m2 (men) determined by echocardiogram within last 24 months.
- •Able and willing to provide written informed consent
排除标准
- •Presence of implantable defibrillator, permanent pacemaker, other metal implant not compatible with 3TMRS/MRI, or other contraindication to 3T MRS/MRI procedures
- •Heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or hypertrophic cardiomyopathy
- •Weight <50 kg or >120 kg
- •Coronary or cerebral atherothrombotic events in the past 6 months
- •Hospitalization of emergency room visit for heart failure within past 3 months
- •ICD shock in last 3 months
- •Known peripheral artery disease or ankle-brachial index <0.9 at screening visit
- •Exercise primarily limited by angina, lung disease or neuromuscular disease
- •Systolic blood pressure <100 or >160 mmHg
- •Heart rate <50 or >110 min-1
- •Estimated glomerular filtration rate <30 ml/min
- •Liver function tests >3 times upper limit of normal
- •Serum phosphate below normal limit
- •Pregnant or breast-feeding women
- •Women of child-bearing potential unwilling to use recommended contraception methods during the study
- •Treatment with oral iron supplements (except multivitamins) in past year
- •Treatment with intravenous iron in past year
- •Treatment with erythropoiesis stimulating agents in the past year
- •Known intolerance of intravenous iron
- •History of anaphylaxis
- •Participation in another clinical trial within last 30 days.
研究组 & 干预措施
Ferric Carboxymaltose
HF patients with functional iron deficiency assigned to receive one-time dose of Ferric Carboxymaltose 750 mg. Participants will undergo serial assessment before and 4 weeks after study drug administration
干预措施: Ferric Carboxymaltose (Drug)
Ferric Carboxymaltose
HF patients with functional iron deficiency assigned to receive one-time dose of Ferric Carboxymaltose 750 mg. Participants will undergo serial assessment before and 4 weeks after study drug administration
干预措施: 31P MRS/MRI (Device)
Placebo
HF patients with functional iron deficiency assigned to receive one-time dose of Placebo (saline injection). Participants will undergo serial assessment before and 4 weeks after study drug administration.
干预措施: Placebo (Drug)
Placebo
HF patients with functional iron deficiency assigned to receive one-time dose of Placebo (saline injection). Participants will undergo serial assessment before and 4 weeks after study drug administration.
干预措施: 31P MRS/MRI (Device)
结局指标
主要结局
Change From Baseline in Post-Exercise Phosphocreatine Recovery Time
时间窗: Baseline, Week 4
Post-exercise phosphocreatine recovery time (in seconds) will be used to assess mitochondrial oxidative capacity. It is measured non-invasively with 31P-magnetic resonance spectroscopy.
次要结局
- Change From Baseline in Kansas City Cardiomyopathy Questionnaire Score(Baseline, Week 4)
- Change From Baseline in Hemoglobin Levels(Baseline, Week 4)
- Change From Baseline in 6-Minute Walk Test Distance(Baseline, Week 4)
- Change From Baseline in Serum Ferritin Levels(Baseline, Week 4)
- Change From Baseline in Transferrin Saturation(Baseline, Week 4)