A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Exercise capacity (Peak VO2)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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%)
Exclusion Criteria
- •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
Arms & Interventions
Initial FCM
Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program
Intervention: Initial FCM (Drug)
Initial FCM
Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program
Intervention: Subsequent exercise training (Behavioral)
Initial exercise
Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
Intervention: Initial exercise training (Behavioral)
Initial exercise
Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
Intervention: Subsequent FCM (Drug)
Outcomes
Primary Outcomes
Exercise capacity (Peak VO2)
Time Frame: Change from baseline to 4 months
Peak VO2 is measured by spiroergometry
Secondary Outcomes
- 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)
Investigators
Dr. Harm Wienbergen
Head of the Bremen Institute for Heart and Circulation Research (BIHKF)
Herzzentrum Bremen