Heart Failure With Reduced Ejection FractionIronExNCT03803111
Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
A study testing Initial exercise training, Initial FCM and Subsequent FCM in people with Heart Failure With Reduced Ejection Fraction and Exercise Training, run by Herzzentrum Bremen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Exercise Training, Ferric Carboxymaltose
- What is being tested?
- Initial exercise training, Initial FCM and Subsequent FCM
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
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.
Read the 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.
- Being tested
- Initial exercise training, Initial FCM, Subsequent FCM, Subsequent exercise training
- Keywords
- Heart Failure with Reduced Ejection Fraction, Exercise Training Program, Iron Deficiency
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial exercise trainingBehavioural
Initial exercise training program
Initial FCMDrug
Initial intravenous iron supplementation (FCM)
Subsequent FCMDrug
Subsequent intravenous iron Supplementation (FCM) after 2 months
Subsequent exercise trainingBehavioural
Subsequent exercise training program after 2 months
| Study group | Role | What they receive |
|---|---|---|
| Initial FCM | Experimental | Intravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program Receives: Drug: Initial FCM; Behavioral: Subsequent exercise training |
| Initial exercise | Experimental | Exercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM Receives: Behavioral: Initial exercise training; Drug: Subsequent FCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity (Peak VO2)
Peak VO2 is measured by spiroergometry
Measured: Change from baseline to 4 months
Secondary outcomes (4)
6 Minute walking distance
To further assess exercise capacity
Measured: 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)
To assess symptoms
Measured: Improvement or deterioration of NYHA class from baseline to 4 months
Echocardiographic ejection fraction of left ventricular function (measured in %, the lower the worse)
Systolic and diastolic function, chamber diameters, strain analyses
Measured: Improvement or deterioration of ejection fraction from baseline to 4 months
Combined endpoint cardiovascular hospitalizations and death
To assess major events
Measured: After 2 and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start1 Jan 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Why it stopped: Sponsoring and Screening of first patients was not sufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herzzentrum Bremen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harm Wienbergen, Herzzentrum Bremen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803111
- Sponsor's protocol ID
- BIHKF-7162
- Acronym
- IronEx
- Status last verified
- Mar 2022
- First submitted
- 8 Jan 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial on Sequential Effects of Iron Therapy and Exercise Training in Patients With Heart Failure and Iron Deficiency
- ClinicalTrials.gov ID
- NCT03803111
- Acronym / sponsor ID
- IronEx / BIHKF-7162
- Keywords
- Heart Failure with Reduced Ejection Fraction, Exercise Training Program, Iron Deficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsoring and Screening of first patients was not sufficient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herzzentrum BremenUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial FCM | Experimental | Drug: Initial FCM, Behavioral: Subsequent exercise trainingIntravenous iron supplementation with FCM, subsequent (after 2 months) exercise training program |
| Initial exercise | Experimental | Behavioral: Initial exercise training, Drug: Subsequent FCMExercise training program, subsequent (after 2 months) intravenous iron supplementation with FCM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial exercise trainingInitial exercise training program | Behavioural | Initial exercise |
| Initial FCMInitial intravenous iron supplementation (FCM) | Drug | Initial FCM |
| Subsequent FCMSubsequent intravenous iron Supplementation (FCM) after 2 months | Drug | Initial exercise |
| Subsequent exercise trainingSubsequent exercise training program after 2 months | Behavioural | Initial FCM |
Primary outcome
Exercise capacity (Peak VO2)
Time frame: Change from baseline to 4 months
Peak VO2 is measured by spiroergometry
4 secondary outcomes
6 Minute walking distance
Time frame: 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)
Time frame: Improvement or deterioration of NYHA class from baseline to 4 months
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
Combined endpoint cardiovascular hospitalizations and death
Time frame: After 2 and 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial exercise training, Initial FCM and Subsequent FCM in people with Heart Failure With Reduced Ejection Fraction and Exercise Training, run by Herzzentrum Bremen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (Peak VO2) (time frame: Change from baseline to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.