A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Exercise capacity (Peak VO2)
研究概览
简要总结
It is the aim of the study to prove, if intravenous supplementation with ferric carboxymaltose in iron-deficient patients with heart failure with reduced ejection fraction (HFrEF) leads to better exercise training effects compared to exercise training without previous iron supplementation.
详细描述
In patients with heart failure with reduced ejection fraction (HFrEF) exercise training (ET) is recommended. In iron-deficient HFrEF patients iron supplementation by ferric carboxymaltose (FCM) is recommended. Both treatment options (ET and iron supplementation) affect oxidative metabolism.
In this study iron-deficient HFrEF patients are included and randomly assigned to two study arms:
Study arm A: Intravenous iron supplementation with FCM, subsequent (after 2 months) ET program.
Study arm B: ET program, subsequent (after 2 months) intravenous iron supplementation with FCM.
Primary study endpoint is exercise capacity (Peak VO2). Secondary endpoints are 6-minute walking distance, NYHA class, echocardiographic parameters and the combined endpoint cardiovascular hospitalizations and death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Heart failure with reduced ejection fraction ≤ 40%
- •New York Heart Failure Asssociation class II-III
- •Iron deficiency (ferritin < 100 ng/ml or 100-299 ng/ml, if transferrin saturation < 20%)
排除标准
- •Planned cardiovascular interventions (such as bypass surgery or valve interventions)
- •Acute coronary Syndrome
- •Malignant rhythm disturbances
- •Acute or chronic infection
- •Reduced prognosis or exercise capacity by non-cardiac comorbidities
- •Missing informed consent
研究组 & 干预措施
Initial FCM
Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program
干预措施: Initial FCM (Drug)
Initial FCM
Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program
干预措施: Subsequent exercise training (Behavioral)
Initial exercise
Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
干预措施: Initial exercise training (Behavioral)
Initial exercise
Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
干预措施: Subsequent FCM (Drug)
结局指标
主要结局
Exercise capacity (Peak VO2)
时间窗: Change from baseline to 4 months
Peak VO2 is measured by spiroergometry
次要结局
- 6 Minute walking distance(Change from baseline to 4 months)
- Combined endpoint cardiovascular hospitalizations and death(After 2 and 4 months)
- New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status)(Improvement or deterioration of NYHA class from baseline to 4 months)
- Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse)(Improvement or deterioration of ejection fraction from baseline to 4 months)
研究者
Dr. Harm Wienbergen
Head of the Bremen Institute for Heart and Circulation Research (BIHKF)
Herzzentrum Bremen