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Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency (IronEx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03803111
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Dr. Harm Wienbergen, Herzzentrum Bremen

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.

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Exercise Training Ferric Carboxymaltose Behavioral: Initial exercise training Drug: Initial FCM Drug: Subsequent FCM Behavioral: Subsequent exercise training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Initial FCM
Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program
Drug: Initial FCM
Initial intravenous iron supplementation (FCM)

Behavioral: Subsequent exercise training
Subsequent exercise training program after 2 months

Experimental: Initial exercise
Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM
Behavioral: Initial exercise training
Initial exercise training program

Drug: Subsequent FCM
Subsequent intravenous iron Supplementation (FCM) after 2 months

Primary Outcome Measures :
  1. Exercise capacity (Peak VO2) [ Time Frame: Change from baseline to 4 months ]
    Peak VO2 is measured by spiroergometry

Secondary Outcome Measures :
  1. 6 Minute walking distance [ Time Frame: Change from baseline to 4 months ]
    To further assess exercise capacity

  2. New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status) [ Time Frame: Improvement or deterioration of NYHA class from baseline to 4 months ]
    To assess symptoms

  3. Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse) [ Time Frame: Improvement or deterioration of ejection fraction from baseline to 4 months ]
    Systolic and diastolic function, chamber diameters, strain analyses

  4. Combined endpoint cardiovascular hospitalizations and death [ Time Frame: After 2 and 4 months ]
    To assess major events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
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Responsible Party: Dr. Harm Wienbergen, Head of the Bremen Institute for Heart and Circulation Research (BIHKF), Herzzentrum Bremen Identifier: NCT03803111    
Other Study ID Numbers: BIHKF-7162
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Harm Wienbergen, Herzzentrum Bremen:
Heart Failure with Reduced Ejection Fraction
Exercise Training Program
Iron Deficiency
Additional relevant MeSH terms:
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Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases