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Heart Failure, SystolicPhase 2Iron TurtleNCT03079518

Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency

A Phase 2 study testing Ferric Carboxymaltose and blood withdrawal in people with Heart Failure, Systolic and Iron Deficiency, run by RWTH Aachen University at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up ("main") study. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Systolic, Iron Deficiency
What is being tested?
Ferric Carboxymaltose and blood withdrawal
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteGermany
Study dates
10 Mar 2017to 25 Oct 2017
Phase
Phase 2
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

  • Written informed consent.
  • Age > 18 yrs
  • Symptomatic HFREF (LV ejection fraction < 45%) with optimal medical therapy (OMT) for at least 2 months
  • Iron deficiency as indicated by by ferritin <100 ng/mL or ferritin 100-299 ng/ml when transferrin saturation (TSAT) <20% and Hb value < 13mg/dl (women) and <14 mg/dl (men)
  • Group A: Stable CKD for at least 2 months, defined by estimated glomerular filtration rate (eGFR) (CKD-EPI formula) as 15-60 ml/min/1,73 m3 (CKD III, IV, V-non D)
  • Group B: patients with stable eGFR > 60 ml/min/1,73 m3

Who cannot join

  • Known hypersensitivity to ferric carboxymaltose or any constituents of the formulation,
  • Plasma Phosphate < 2.5 mg/dL at screening,
  • Renal replacement therapy/transplantation,
  • Pregnancy or lactation
  • iron substitution therapy or erythropoetin (epo) therapy within 6 weeks before
  • participation in another clinical trial with an experimental drug
Show all 10Show fewer
  • expectation of missing compliance
  • alcohol or drug abuse
  • The subject is mentally or legally incapacitated
  • patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

Other trials in Germany

About this study

Official title: Intravenous Iron in paTients With Heart failURe and Reduced Ejection fracTion (HFREF) pLus Iron dEficiency: Effects Upon Phosphate and FGF23 Metabolism

Effects of ferric carboxymaltose single HD (1000 mg) infusion upon FGF23 in patients with isolated HFREF compared to patients with HFREF+CKD (all pts with iron deficiency). This study aims at identification of the optimal target population for a follow-up ("main") study.

Read the detailed description

Iron deficiency is highly prevalent in patients with HFREF and intravenous high-dose (HD) iron application has significantly improved clinically meaningful endpoints in such patients. The best evidence is existent for ferric carboxymaltose. Intravenous HD iron may influence phosphate metabolism via increases in levels of intact FGF23 and hence induce prolonged hypophosphatemia. Such increases in FGF23 may particularly occur depending on the type of iron carrier.

FGF23 is a significant risk factor for mortality and morbidity in patients with HFREF and other cardiac populations at risk and may directly cause left ventricular hypertrophy and dysfunction. Hence, the application of i.v. HD iron may have potentially beneficial effects on cardiac function but harmful effects via FGF23-induction and hypophosphatemia at the same time. However, FGF23 metabolism has not yet been evaluated in HFREF patients following i.v. HD iron.

FGF23 is elevated in patients with chronic kidney disease. Patients with HFREF + CKD = chronic cardio-renal syndrome are at particular risk regarding elevated morbidity and mortality. The effects of intravenous HD iron upon phosphate and FGF23 metabolism in patients with HFREF + CKD is unknown and effects in this setting may be different compared to effects in patients without pre-existing FGF23 stimulation.

Being tested
Ferric Carboxymaltose, blood withdrawal
Keywords
iron deficiency, HFREF, FGF23, ferric carboxymaltose
Medical subject headings
Heart Failure, Systolic, Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric CarboxymaltoseDrug

    Also called Ferinject

    single shot infusion

  • blood withdrawalOther

    for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters

Study groups in NCT03079518
Study groupRoleWhat they receive
Patients with HFREF & CKDActive comparatortreated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal
Receives: Drug: Ferric Carboxymaltose; Other: blood withdrawal
Patients with HFREFActive comparatortreated with intravenous single-shot 1000mg Ferric Carboxymaltose infusion; additional intervention: blood withdrawal
Receives: Drug: Ferric Carboxymaltose; Other: blood withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in blood intact FGF23 after infusion of 1000 mg ferric carboxymaltose

    intact FGF23 concentration in kRU/l

    Measured: 4 weeks

  2. changes in blood c-term FGF23 after infusion of 1000 mg ferric carboxymaltose

    c-terminal FGF23 concentration in kRU/l

    Measured: 4 weeks

Secondary outcomes (4)

  1. changes of serum biomarkers of chronic kidney disease metabolism

    PTH, Vitamin D, ALP, s-klotho, PINP, proBNP

    Measured: 4 weeks

  2. changes of urinary marker of tubular damage

    NGAL, KIM-1

    Measured: 4 weeks

  3. phosphate level

    < 1,25 mg/dL

    Measured: 4 weeks

  4. changes of Inflammatory mediators

    IL1, IL6, TNF-alpha, hsCRP

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2017
  2. Study start10 Mar 2017
  3. Primary completion25 Oct 2017
  4. Study completion25 Oct 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03079518
Sponsor's protocol ID
16-047
Acronym
Iron Turtle
Status last verified
Dec 2017
First submitted
3 Mar 2017
Last updated
6 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared due to publication afterwards

Publications

  • Stohr R, Sandstede L, Heine GH, Marx N, Brandenburg V. High-Dose Ferric Carboxymaltose in Patients With HFrEF Induces Significant Hypophosphatemia. J Am Coll Cardiol. 2018 May 15;71(19):2270-2271. doi: 10.1016/j.jacc.2018.03.448. No abstract available.

    PubMed 29747838

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ferric Carboxymaltose and blood withdrawal in people with Heart Failure, Systolic and Iron Deficiency, run by RWTH Aachen University 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 6 Dec 2017. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

changes in blood intact FGF23 after infusion of 1000 mg ferric carboxymaltose (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03079518, which also lists 1 linked publication.

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 6 Dec 2017.

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