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

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ClinicalTrials.gov Identifier: NCT03803111
Recruitment Status : Not yet recruiting
First Posted : January 14, 2019
Last Update Posted : February 17, 2020
Sponsor:
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
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
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Responsible Party: Dr. Harm Wienbergen, Head of the Bremen Institute for Heart and Circulation Research (BIHKF), Herzzentrum Bremen
ClinicalTrials.gov 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
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases