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

Primary Purpose

Heart Failure With Reduced Ejection Fraction, Exercise Training, Ferric Carboxymaltose

Status

Withdrawn

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Initial exercise training

Initial FCM

Subsequent FCM

Subsequent exercise training

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring Heart Failure with Reduced Ejection Fraction, Exercise Training Program, Iron Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bremer Institut für Herz- und Kreislaufforschung

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Initial FCM

Initial exercise

Arm Description

Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program

Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM

Outcomes

Primary Outcome Measures

Exercise capacity (Peak VO2)

Peak VO2 is measured by spiroergometry

Secondary Outcome Measures

6 Minute walking distance

To further assess exercise capacity

New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status)

To assess symptoms

Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse)

Systolic and diastolic function, chamber diameters, strain analyses

Combined endpoint cardiovascular hospitalizations and death

To assess major events

Full Information

NCT ID

NCT03803111

First Posted

January 8, 2019

Last Updated

March 15, 2022

Sponsor

Herzzentrum Bremen

1. Study Identification

Unique Protocol Identification Number

NCT03803111

Brief Title

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

Acronym

IronEx

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

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Sponsoring and Screening of first patients was not sufficient

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

March 15, 2022 (Actual)

Study Completion Date

March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herzzentrum Bremen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure With Reduced Ejection Fraction, Exercise Training, Ferric Carboxymaltose

Keywords

Heart Failure with Reduced Ejection Fraction, Exercise Training Program, Iron Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Initial FCM

Arm Type

Experimental

Arm Description

Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program

Arm Title

Initial exercise

Arm Type

Experimental

Arm Description

Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM

Intervention Type

Behavioral

Intervention Name(s)

Initial exercise training

Intervention Description

Initial exercise training program

Intervention Type

Drug

Intervention Name(s)

Initial FCM

Intervention Description

Initial intravenous iron supplementation (FCM)

Intervention Type

Drug

Intervention Name(s)

Subsequent FCM

Intervention Description

Subsequent intravenous iron Supplementation (FCM) after 2 months

Intervention Type

Behavioral

Intervention Name(s)

Subsequent exercise training

Intervention Description

Subsequent exercise training program after 2 months

Primary Outcome Measure Information:

Title

Exercise capacity (Peak VO2)

Description

Peak VO2 is measured by spiroergometry

Time Frame

Change from baseline to 4 months

Secondary Outcome Measure Information:

Title

6 Minute walking distance

Description

To further assess exercise capacity

Time Frame

Change from baseline to 4 months

Title

New York Heart Association class (class I, II, III, IV with class I = best status, and class IV = worst status)

Description

To assess symptoms

Time Frame

Improvement or deterioration of NYHA class from baseline to 4 months

Title

Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse)

Description

Systolic and diastolic function, chamber diameters, strain analyses

Time Frame

Improvement or deterioration of ejection fraction from baseline to 4 months

Title

Combined endpoint cardiovascular hospitalizations and death

Description

To assess major events

Time Frame

After 2 and 4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Bremer Institut für Herz- und Kreislaufforschung

City

Bremen

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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