Chronic Heart FailurePhase 1/2NCT00125996
Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure
A Phase 1/2 study testing Venofer (intravenous iron sucrose) in people with Chronic Heart Failure and Heart Diseases, run by National Heart and Lung Institute at 2 sites in 2 countries.
Trial summary
This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF). Read more about this study
- Who is it for?
- Ages 30 to 95 years
- Conditions the study is for
- Chronic Heart Failure, Heart Diseases, Anemia, Iron-Deficiency
- What is being tested?
- Venofer (intravenous iron sucrose)
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2004to Feb 2006
- Phase
- Phase 1/2
- 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 30 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥21 years of age and have signed written informed consent
- Stable symptomatic CHF; NYHA III/IV and left ventricular ejection fraction (LVEF) ≤40%, or if NYHA II then LVEF must be ≤35%, as assessed within last 6 months using echocardiographic or magnetic resonance imaging techniques.
- On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
- Peak VO2 ≤ 18 ml/kg/min on modified Naughton protocol cardiopulmonary exercise testing.
- Mean of the 2 screening Hb concentrations (week-2 and week-1) < 12.5 g/dl (anaemic group, 50% of study population) or 12.5-14.0 g/dl (non-anaemic group, 50% of study population).
- Ferritin <100 µg/l or 100-300 µg/l with TSAT <20%.
- Normal red cell folate and vitamin B12 status (according to local lab reference range).
- Resting blood pressure ≤160/100 mmHg.
Who cannot join
- History of acquired iron overload; known haemochromatosis or first relatives with haemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
- Known hypersensitivity to parental iron preparations.
- Known active infection, bleeding, malignancy and haemolytic anaemia.
- History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
- Recipient of immunosuppressive therapy or renal dialysis.
- History of erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days.
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- Unstable angina pectoris, as judged by the investigator; severe uncorrected valvular disease or left ventricular outflow obstruction; obstructive cardiomyopathy; uncontrolled fast atrial fibrillation or flutter (heart rate >110 beats per minute [bpm]); uncontrolled symptomatic brady- or tachyarrhythmias.
- Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
- Pregnant or breast-feeding
- Inability to comprehend study protocol
- Parallel participation in another clinical trial
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site, 1 recruiting
- Recruiting
4th Military Clinical Hospital
Weigla 5, Wroclaw, 50981
Piotr Ponikowski, MD PHD, (48) 717660250, piotrponikowski@hotmail.com
Piotr Ponikowski, MD PHD
United Kingdom1 site, 1 recruiting
- Recruiting
Wexham Park Hospital
Wexham Park, Slough, Berkshire, SL2 4HL
Constantinous Missouris, MD, (44)01753 634680, cmissouris@btopenworld.com
Amit K Mandall, MRCP, (44)01753 634680, akjm@mac.com
About this study
Official title: A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure
This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF).
The hypotheses are:
- Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2.
- IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
Read the detailed description
Study Phase and Design:
Prospective two-centre, randomized, controlled, open-label, observer-blinded, parallel-group study
Primary Objective:
To evaluate the effect of intravenous (IV) iron supplementation on exercise tolerance, as determined by peak VO2.
Secondary Objectives:
- To evaluate the effects of IV iron supplementation on exercise duration, left ventricular (LV) structure and function, symptom status (NYHA class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], and subjective fatigue score), and haematological and biochemical (haemoglobin [Hb], haematocrit [Hct], iron status, N-BNP, cytokines and oxidative stress) indices.
- To evaluate the safety profile of IV iron in subjects with moderate to severe CHF.
Sample Size:
42 subjects (28 IV iron, 14 placebo); 50% anaemic and 50% non-anaemic
- Being tested
- Venofer (intravenous iron sucrose)
- Keywords
- ANAEMIA, Iron Deficiency
- Medical subject headings
- Heart Diseases, 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.
Venofer (intravenous iron sucrose)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak VO2 from baseline to week 18
Secondary outcomes (8)
Change in cardiopulmonary exercise duration from baseline to week 18
Change in distance walked during 6 minute walk test from baseline to end of repletion phase in treatment group or week 8 in control group, and week 18
Change in left ventricular (LV) systolic and diastolic dimensions, and function from baseline to week 18
Change in symptom status (New York Heart Association [NYHA] class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], visual analogue fatigue scale) from baseline to week 1,week 8, and week 18
Change in haematological and biochemical indices (Hb, Hct, iron status, N-BNP, cytokines and oxidative stress) from baseline to week 18
Number and incidence of adverse events
Changes in liver function tests and renal function tests
Changes in vital parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2005 (estimated)
- Study startJul 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 42 participants
Sponsor and investigators
- Lead sponsor
- National Heart and Lung Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Wexham Park Hospital, 4th Military Clinical Hospital with Polyclinic, Poland
- Investigators
- Philip A Poole-Wilson, MD,FRCP, Principal investigator, NHLI, Imperial College School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125996
- Sponsor's protocol ID
- FERRIC-HF
- Other IDs
- FERRIC-Hef1, RD010, 131/03L
- Status last verified
- Jan 2005
- First submitted
- 1 Aug 2005
- Last updated
- 17 Aug 2005
- Results posted
- No
Publications
Okonko DO, Grzeslo A, Witkowski T, Mandal AK, Slater RM, Roughton M, Foldes G, Thum T, Majda J, Banasiak W, Missouris CG, Poole-Wilson PA, Anker SD, Ponikowski P. Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC-HF: a randomized, controlled, observer-blinded trial. J Am Coll Cardiol. 2008 Jan 15;51(2):103-12. doi: 10.1016/j.jacc.2007.09.036.
PubMed 18191732
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00125996
- Acronym / sponsor ID
- FERRIC-HF
- Keywords
- ANAEMIA, Iron Deficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants
- Lead sponsor
- National Heart and Lung InstituteUniversity, hospital or other
- Collaborators
- Wexham Park Hospital, 4th Military Clinical Hospital with Polyclinic, Poland
- Study start
- Jul 2004
- Study completion
- Feb 2006
- First posted
- 2 Aug 2005 (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.
This is a two-center, randomised, single-blind (physician), prospective, controlled study to assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose supplementation in anaemic and non-anaemic iron deficient patients with chronic heart failure (CHF).
The hypotheses are:
- Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose improves exercise capacity as measured by peak VO2.
- IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
Detailed description
Study Phase and Design:
Prospective two-centre, randomized, controlled, open-label, observer-blinded, parallel-group study
Primary Objective:
To evaluate the effect of intravenous (IV) iron supplementation on exercise tolerance, as determined by peak VO2.
Secondary Objectives:
- To evaluate the effects of IV iron supplementation on exercise duration, left ventricular (LV) structure and function, symptom status (NYHA class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], and subjective fatigue score), and haematological and biochemical (haemoglobin [Hb], haematocrit [Hct], iron status, N-BNP, cytokines and oxidative stress) indices.
- To evaluate the safety profile of IV iron in subjects with moderate to severe CHF.
Sample Size:
42 subjects (28 IV iron, 14 placebo); 50% anaemic and 50% non-anaemic
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 30 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥21 years of age and have signed written informed consent
- Stable symptomatic CHF; NYHA III/IV and left ventricular ejection fraction (LVEF) ≤40%, or if NYHA II then LVEF must be ≤35%, as assessed within last 6 months using echocardiographic or magnetic resonance imaging techniques.
- On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
- Peak VO2 ≤ 18 ml/kg/min on modified Naughton protocol cardiopulmonary exercise testing.
- Mean of the 2 screening Hb concentrations (week-2 and week-1) < 12.5 g/dl (anaemic group, 50% of study population) or 12.5-14.0 g/dl (non-anaemic group, 50% of study population).
Key exclusion criteria (11 listed)
- History of acquired iron overload; known haemochromatosis or first relatives with haemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
- Known hypersensitivity to parental iron preparations.
- Known active infection, bleeding, malignancy and haemolytic anaemia.
- History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
- Recipient of immunosuppressive therapy or renal dialysis.
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 |
|---|---|---|
| Venofer (intravenous iron sucrose) | Drug | – |
Primary outcome
Change in peak VO2 from baseline to week 18
8 secondary outcomes
Change in cardiopulmonary exercise duration from baseline to week 18
Change in distance walked during 6 minute walk test from baseline to end of repletion phase in treatment group or week 8 in control group, and week 18
Change in left ventricular (LV) systolic and diastolic dimensions, and function from baseline to week 18
Change in symptom status (New York Heart Association [NYHA] class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], visual analogue fatigue scale) from baseline to week 1,week 8, and week 18
Change in haematological and biochemical indices (Hb, Hct, iron status, N-BNP, cytokines and oxidative stress) from baseline to week 18
Number and incidence of adverse events
Changes in liver function tests and renal function tests
Changes in vital parameters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2005.
- Derived from this study: PubMed 18191732Okonko DO, Grzeslo A, Witkowski T, Mandal AK, Slater RM, Roughton M, Foldes G, Thum T, Majda J, Banasiak W, Missouris CG, Poole-Wilson PA, Anker SD, Ponikowski P. Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC-HF: a randomized, controlled, observer-blinded trial. J Am Coll Cardiol. 2008 Jan 15;51(2):103-12. doi: 10.1016/j.jacc.2007.09.036.
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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.
Philip A Poole-Wilson, MD,FRCP principal investigator
NHLI, Imperial College School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Venofer (intravenous iron sucrose) in people with Chronic Heart Failure and Heart Diseases, run by National Heart and Lung Institute at 2 sites in 2 countries.
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 11 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: status not confirmed, as of the sponsor's last update on 17 Aug 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland, United Kingdom. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darlington O Okonko, BSc, MRCP (02073518700, D.OKONKO@IC.AC.UK), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak VO2 from baseline to week 18. 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 NCT00125996, 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 17 Aug 2005.