Clinical trial NCT03803111: Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
Official title: A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Exercise Training
Ferric Carboxymaltose
Keywords: Heart Failure with Reduced Ejection Fraction
Exercise Training Program
Iron Deficiency
Lead sponsor: Herzzentrum Bremen
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise capacity (Peak VO2)
timeFrame: Change from baseline to 4 months
Secondary outcomes:
measure: 6 Minute walking distance
timeFrame: Change from baseline to 4 months
measure: New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status)
timeFrame: Improvement or deterioration of NYHA class from baseline to 4 months
measure: Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse)
timeFrame: Improvement or deterioration of ejection fraction from baseline to 4 months
measure: Combined endpoint cardiovascular hospitalizations and death
timeFrame: After 2 and 4 months
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Bremer Institut für Herz- und Kreislaufforschung
Study officials:
References: