Heart FailurePhase 4NCT01925703
Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
A Phase 4 study testing Sodium ferric gluconate in people with Heart Failure and Iron Deficiency Anemia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Iron Deficiency Anemia
- What is being tested?
- Sodium ferric gluconate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age > 18 years
- Admission to the general cardiology or heart failure services and under the care of a cardiologist at the study institution
- New York Heart Association Class II-IV heart failure
- Ejection fraction < 40%
- Serum hemoglobin < 12.0 g/dL
- Ferritin < 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) < 20%
- Patients deemed by an attending physician to require intravenous iron therapy based on previous attempts to correct iron deficiency or other patient-specific circumstances
Who cannot join
- Anemia of other known etiology (e.g., malignancy, malabsorption syndromes)
- Use of iron or erythropoietin-stimulating agents within previous 12 weeks
- Blood transfusion within previous 12 weeks; additionally, if patients receive blood transfusions during the study period, they will remain in the safety analysis but will be excluded from efficacy analysis
- Active bleeding
- Known infection at admission
- Immunosuppressant therapy
Show all 9Show fewer
- Renal replacement therapy
- Known pregnancy
- Any other criteria deemed by the attending physician to warrant exclusion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Hospitals & Clinics
Chapel Hill, North Carolina, 27514
About this study
Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.
Read the detailed description
The purpose of this pilot investigation is to evaluate the short-term hematologic effects and safety of an accelerated intravenous iron regimen in patients with heart failure and iron deficiency. Recent investigations have demonstrated improved clinical outcomes with the use of intravenous iron therapy in this patient population, but a weekly regimen administered to ambulatory patients may be inconvenient, impractical, and associated with less than optimal adherence rates for many patients, especially those with reduced functional capacity. The heart failure population is characterized by frequent hospitalizations, which would make an accelerated inpatient regimen a convenient and attractive option for improving heart failure symptoms, exercise tolerance, and quality of life. Accelerated regimens have been demonstrated as being both safe and effective in other patient populations, but no studies to date have evaluated this strategy in hospitalized patients with heart failure.
- Conditions
- Heart Failure, Iron Deficiency Anemia
- Being tested
- Sodium ferric gluconate
- Medical subject headings
- Heart Failure, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ferric gluconateDrug
Also called Ferrlecit
Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| Sodium ferric gluconate | Experimental | Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first. Receives: Drug: Sodium ferric gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Hemoglobin Concentration
Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Measured: Baseline and at follow-up within 1-4 weeks
Secondary outcomes (2)
Transferrin Saturation
Change in transferrin saturation compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Measured: Baseline and at follow-up within 1-4 weeks
Serum Ferritin Level
Change in serum ferritin level compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
Measured: Baseline and at follow-up within 1-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startApr 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jo Ellen Rodgers, PharmD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925703
- Sponsor's protocol ID
- 11-0551
- Status last verified
- May 2014
- First submitted
- 30 May 2013
- Last updated
- 25 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01925703
- Acronym / sponsor ID
- 11-0551
- Conditions
- Heart Failure, Iron Deficiency Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.
Detailed description
The purpose of this pilot investigation is to evaluate the short-term hematologic effects and safety of an accelerated intravenous iron regimen in patients with heart failure and iron deficiency. Recent investigations have demonstrated improved clinical outcomes with the use of intravenous iron therapy in this patient population, but a weekly regimen administered to ambulatory patients may be inconvenient, impractical, and associated with less than optimal adherence rates for many patients, especially those with reduced functional capacity. The heart failure population is characterized by frequent hospitalizations, which would make an accelerated inpatient regimen a convenient and attractive option for improving heart failure symptoms, exercise tolerance, and quality of life. Accelerated regimens have been demonstrated as being both safe and effective in other patient populations, but no studies to date have evaluated this strategy in hospitalized patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium ferric gluconate | Experimental | Drug: Sodium ferric gluconateSodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Admission to the general cardiology or heart failure services and under the care of a cardiologist at the study institution
- New York Heart Association Class II-IV heart failure
- Ejection fraction < 40%
- Serum hemoglobin < 12.0 g/dL
Key exclusion criteria (9 listed)
- Anemia of other known etiology (e.g., malignancy, malabsorption syndromes)
- Use of iron or erythropoietin-stimulating agents within previous 12 weeks
- Blood transfusion within previous 12 weeks; additionally, if patients receive blood transfusions during the study period, they will remain in the safety analysis but will be excluded from efficacy analysis
- Active bleeding
- Known infection at admission
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 |
|---|---|---|
| Sodium ferric gluconateAlso: FerrlecitSodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first. | Drug | Sodium ferric gluconate |
Primary outcome
Serum Hemoglobin Concentration
Time frame: Baseline and at follow-up within 1-4 weeks
Change in serum hemoglobin concentration compared to baseline and at follow-up within 1-4 weeks after last intravenous iron infusion
2 secondary outcomes
Transferrin Saturation
Time frame: Baseline and at follow-up within 1-4 weeks
Serum Ferritin Level
Time frame: Baseline and at follow-up within 1-4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Heart Failure
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
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Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
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Active, not recruiting
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RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
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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.
Jo Ellen Rodgers, PharmD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium ferric gluconate in people with Heart Failure and Iron Deficiency Anemia, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 7 inclusion and 9 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 25 Aug 2015. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Hemoglobin Concentration (time frame: Baseline and at follow-up within 1-4 weeks). 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 25 Aug 2015.