Trials Sponsors Conditions Drugs Pricing

Conditions

Exercise Training Ferric Carboxymaltose Heart Failure With Reduced Ejection Fraction

Keywords

Heart Failure with Reduced Ejection FractionExercise Training ProgramIron 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

Study Arms (2)

Initial FCM

EXPERIMENTAL

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

Drug: Initial FCMBehavioral: Subsequent exercise training

Initial exercise

EXPERIMENTAL

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

Behavioral: Initial exercise trainingDrug: Subsequent FCM

Interventions

Initial exercise trainingBehavioral

Initial exercise training program

Initial exercise

Initial FCMDrug

Initial intravenous iron supplementation (FCM)

Initial FCM

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Heart failure with reduced ejection fraction ≤ 40%
New York Heart Failure Asssociation class II-III

Sponsors & Collaborators

Herzzentrum Bremen
Otherlead

Study Sites (1)

Bremer Institut für Herz- und Kreislaufforschung

Bremen, Germany

MeSH Terms

Conditions

Iron Deficiencies

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Enrollment

0 participants (actual enrollment reported by the registry).

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

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Initial FCM

Initial exercise

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Initial FCM

Initial exercise

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations