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

NCT03803111 | Withdrawn

• 1 other identifier: BIHKF-7162
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Exercise capacity (Peak VO2)

  Peak VO2 is measured by spiroergometry

  Change from baseline to 4 months

Secondary Outcomes (4)

• 6 Minute walking distance

  Change from baseline to 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

• Combined endpoint cardiovascular hospitalizations and death

  After 2 and 4 months

Study Arms (2)

Initial FCM

EXPERIMENTAL

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

Drug: Initial FCM; Behavioral: Subsequent exercise training

Initial exercise

EXPERIMENTAL

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

Behavioral: Initial exercise training; Drug: Subsequent FCM

Interventions

Initial exercise training BEHAVIORAL

Initial exercise training program

Initial exercise

Initial FCM DRUG

Initial intravenous iron supplementation (FCM)

Initial FCM

Subsequent FCM DRUG

Subsequent intravenous iron Supplementation (FCM) after 2 months

Initial exercise

Subsequent exercise training BEHAVIORAL

Subsequent exercise training program after 2 months

Initial FCM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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

Sponsors & Collaborators

• Herzzentrum Bremen: lead

Study Sites (1)

Bremer Institut für Herz- und Kreislaufforschung

Bremen, Germany

Location

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Bremen Institute for Heart and Circulation Research (BIHKF)

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 14, 2019
• Study Start: January 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

DE (1)