Heart Failure, SystolicPhase 2/3IRON5NCT02998697
Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia
A Phase 2/3 study testing Ferrous Sulfate in people with Heart Failure, Systolic and Iron-deficiency Anemia, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.
Trial summary
The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Systolic, Iron-deficiency Anemia
- What is being tested?
- Ferrous Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Nov 2016
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 year old
- Systolic heart failure patients without clinical sign of decompensation at outpatient clinic
- New York Heart Association (NYHA) functional class II-III able to perform 6MWT
- LVEF < 50%
- On heart failure therapy
- Haemoglobin (Hb) < 13 gr/dL (male); Hb < 12 gr/dL (female) and > 8 gr/dL
- Ferritin < 100 µg/L or Ferritin 100-300 µg/L dengan Transferrin saturation (Tsat) < 20%
- Agree to participate
Who cannot join
- History of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer
- History of myocardial revascularization (CABG/PCI) within 3 month
- Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month
- Know to have allergic reaction to Ferrous sulfate
- History of intravenous iron administration within 1 month
- Permanent Pace Maker(PPM)/Implantable Cardiac Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT)
Show all 12Show fewer
- estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2
- NT-proBNP > 4000 pg/ml (for patients without baseline data) or decreased level of NT-proBNP < 30% from baseline
- Increase level of serum alanine aminotransferase (ALT)/ serum aspartate aminotransferase (AST)> 3x normal value
- Moderate to severe primary valvular heart disease
- Congenital heart disease
- Right heart failure due to primary pulmonary hypertension, cor pulmonale, Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH)
About this study
Official title: The Effect of Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia
The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA).
Read the detailed description
The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54 Heart Failure (HF) patients (LVEF < 50%) with IDA (Ferritin < 100 ng/mL or 100-300 ng/mL with Tsat < 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT serum lactate levels as secondary end-points.
- Conditions
- Heart Failure, Systolic, Iron-deficiency Anemia
- Being tested
- Ferrous Sulfate, Placebo Oral Capsule
- Keywords
- Systolic Heart Failure, Anemia, Iron Deficiency
- Medical subject headings
- Heart Failure, Systolic, Anemia, Iron-Deficiency, Anemia, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDrug
Also called Ferrous Sulfate oral capsule
Ferrous sulfate 200 mg t.i.d for 90 days
Placebo Oral CapsuleDrug
Lactose 200 mg t.i.d for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Experimental | Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days Receives: Drug: Ferrous Sulfate |
| Control Group | Placebo comparator | Systolic heart failure patients received placebo oral capsule t.i.d for 90 days Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Capacity
Six Minute Walk Test (meter)
Measured: 90 days
Secondary outcomes (5)
Ferritin
Ferritin level (ng/mL)
Measured: 90 days
Transferrin saturation
Transferrin saturation (%)
Measured: 90 days
Haemoglobin
Haemoglobin level (gr/dL)
Measured: 90 days
Echocardiography parameters
Left Ventricle Ejection Fraction
Measured: 90 days
N Terminal-pro Brain Natriuretic Peptide
NT-proBNP level (pg/mL)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lita Dwi Suryani, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Bambang B Siswanto, Professor, Study director, National Cardiovascular Center Harapan Kita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998697
- Sponsor's protocol ID
- LB.02.01/VII/077/KEP.033EV
- Acronym
- IRON5
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2016
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Niehaus ED, Malhotra R, Cocca-Spofford D, Semigran M, Lewis GD. Repletion of Iron Stores With the Use of Oral Iron Supplementation in Patients With Systolic Heart Failure. J Card Fail. 2015 Aug;21(8):694-7. doi: 10.1016/j.cardfail.2015.05.006. Epub 2015 May 29.
PubMed 26028263Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
PubMed 19920054McDonagh T, Macdougall IC. Iron therapy for the treatment of iron deficiency in chronic heart failure: intravenous or oral? Eur J Heart Fail. 2015 Mar;17(3):248-62. doi: 10.1002/ejhf.236. Epub 2015 Jan 30.
PubMed 25639592Suryani LD, Raharjo SB, Sagita R, Angkasa H, Prasetyadi YL, Suyatna FD, Hersunarti N, Soerarso R, Siswanto BB, Muliawan HS. Oral Ferrous Sulphate Improves Functional Capacity on Heart Failure Patients with Iron Deficiency Anemia. Glob Heart. 2022 Nov 22;17(1):81. doi: 10.5334/gh.1151. eCollection 2022.
PubMed 36578916
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia
- ClinicalTrials.gov ID
- NCT02998697
- Acronym / sponsor ID
- IRON5 / LB.02.01/VII/077/KEP.033EV
- Conditions
- Heart Failure, Systolic, Iron-deficiency Anemia
- Keywords
- Systolic Heart Failure, Anemia, Iron Deficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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.
The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA).
Detailed description
The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54 Heart Failure (HF) patients (LVEF < 50%) with IDA (Ferritin < 100 ng/mL or 100-300 ng/mL with Tsat < 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT serum lactate levels as secondary end-points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Drug: Ferrous SulfateSystolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days |
| Control Group | Placebo comparator | Drug: Placebo Oral CapsuleSystolic heart failure patients received placebo oral capsule t.i.d for 90 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 year old
- Systolic heart failure patients without clinical sign of decompensation at outpatient clinic
- New York Heart Association (NYHA) functional class II-III able to perform 6MWT
- LVEF < 50%
- On heart failure therapy
Key exclusion criteria (12 listed)
- History of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer
- History of myocardial revascularization (CABG/PCI) within 3 month
- Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month
- Know to have allergic reaction to Ferrous sulfate
- History of intravenous iron administration within 1 month
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 |
|---|---|---|
| Ferrous SulfateAlso: Ferrous Sulfate oral capsuleFerrous sulfate 200 mg t.i.d for 90 days | Drug | Treated Group |
| Placebo Oral CapsuleLactose 200 mg t.i.d for 90 days | Drug | Control Group |
Primary outcome
Functional Capacity
Time frame: 90 days
Six Minute Walk Test (meter)
5 secondary outcomes
Ferritin
Time frame: 90 days
Transferrin saturation
Time frame: 90 days
Haemoglobin
Time frame: 90 days
Echocardiography parameters
Time frame: 90 days
N Terminal-pro Brain Natriuretic Peptide
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
- Results publication: PubMed 26028263Niehaus ED, Malhotra R, Cocca-Spofford D, Semigran M, Lewis GD. Repletion of Iron Stores With the Use of Oral Iron Supplementation in Patients With Systolic Heart Failure. J Card Fail. 2015 Aug;21(8):694-7. doi: 10.1016/j.cardfail.2015.05.006. Epub 2015 May 29.
- Results publication: PubMed 19920054Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
- Results publication: PubMed 25639592McDonagh T, Macdougall IC. Iron therapy for the treatment of iron deficiency in chronic heart failure: intravenous or oral? Eur J Heart Fail. 2015 Mar;17(3):248-62. doi: 10.1002/ejhf.236. Epub 2015 Jan 30.
- Derived from this study: PubMed 36578916Suryani LD, Raharjo SB, Sagita R, Angkasa H, Prasetyadi YL, Suyatna FD, Hersunarti N, Soerarso R, Siswanto BB, Muliawan HS. Oral Ferrous Sulphate Improves Functional Capacity on Heart Failure Patients with Iron Deficiency Anemia. Glob Heart. 2022 Nov 22;17(1):81. doi: 10.5334/gh.1151. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Bambang B Siswanto, Professor study director
National Cardiovascular Center Harapan Kita
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ferrous Sulfate in people with Heart Failure, Systolic and Iron-deficiency Anemia, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.
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 8 inclusion and 12 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 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Functional Capacity (time frame: 90 days). 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 NCT02998697, which also lists 4 linked publications.
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 20 Dec 2016.