Myocardial Iron OverloadHEMOCOEURNCT02099214
Estimation of Myocardial Iron Overload by 3 Tesla MRI in HFE Hereditary Haemochromatosis
A study testing 3Tesla cardiac MRI, Electrocardiogram (EKG) and Iron and cardiac markers in people with Myocardial Iron Overload and HFE-Associated Hereditary Hemochromatosis, run by Rennes University Hospital at 1 site in France.
Trial summary
Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible first for biological disorder in blood iron parameters and minor clinical disorders, before evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Iron Overload, HFE-Associated Hereditary Hemochromatosis
- What is being tested?
- 3Tesla cardiac MRI, Electrocardiogram (EKG) and Iron and cardiac markers
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2014to 18 Oct 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients :
- Adults older than 18 ;
- Newly diagnosed with HFE hereditary haemochromatosis by genetic testing (homozygous for the C283Y mutation on HFE gene);
- Treatment-naive;
- Showing a ferritin level higher than 200µg/l for women and higher than 300µg/L for men;
- Affiliated to French Social Security;
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- Having given a written informed consent.
- Healthy volunteers:
- Adults older than 18;
- Presenting all the following criterions:
- Normal cardiovascular physical examination: no signs of cardiac insufficiency, no pathological cardiac murmur, normal EKG (regular sinus rhythm, no high degree AV nor ventricular blocks, no rhythm anomaly),
- Body Mass Index <27 kg/m²,
- Normal routine blood biology (blood count, MCV, serum iron, ferritin, transferrin saturation);
- Affiliated to French Social Security;
- Having given a written informed consent.
Who cannot join
- Patients :
- MRI-related criterions :
- Cardiac pacemaker or implanted defibrillator ;
- Non MRI-compatible prosthetic cardiac valve;
- Non MRI-compatible clips/stents/coils/etc.;
- Cochlear implant;
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- Peripheral or neuronal stimulator;
- Intra-ocular or brain metallic foreign bodies , foreign body in the eyes' vicinity, shrapnel or firearm wound;
- Less than 4 weeks-old stents, less than 6 weeks-old osteosynthesis materials;
- Claustrophobia;
- Pumps, tattoos, permanent makeup, intrauterine device, patches;
- Non-removable metallic or magnetic material in the vicinity of the analysed field.
- Other criterions :
- Haemodynamic instability / Acute respiratory insufficiency / Altered general status / Need for continuous monitoring incompatible wih MRI confines;
- Pregnancy, breast feeding;
- History of blood transfusion or iron supplementation;
- Blood donation in the last 3 months;
- Infection in the 7 days prior to the first visit;
- Stay in altitude (>1500m) in the past 2 months;
- Adults under legal protective regimen or deprived of liberty.
- Healthy volunteers
- Alcohol abuse (>20g per day for women, >30g per day for men);
- Active tobacco intoxication or smoking cessation in the 6 last months;
- Personal cardiovascular medical history;
- Cardiovascular functional signs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study
Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible first for biological disorder in blood iron parameters and minor clinical disorders, before evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and congestive heart failure.
The improvement of screening and treatments made those severe affections rare enough not to evaluate myocardial iron overload a systematic part of the starting check-up. Nonetheless this myocardial iron overload might have severe implications on cardiac function on a long term basis.
Read more
A single trial was conducted on limited number of patients with 1.5 Tesla MRI, which showed a myocardial iron overload (defined by a myocardium T2* value <20ms) in 19% of the subjects.
The main objective of this study is to precisely estimate cardiac iron overload in treatment naive patients with newly diagnosed HFE hereditary haemochromatosis with a 3 Tesla MRI, more sensitive than the 1.5 Tesla one, in order to later appreciate its correlation with cardiac morbidity in HHC.
Read the detailed description
Since the wide use of phlebotomy was implemented the incidence of congestive heart failure in HHC became quite low. As such, the interest towards the initial diagnosis and cardiological follow-up has been lesser. A subclinical myocardial iron overload can nevertheless exist and eventually lead to functional consequences in the medium and long term if neglected, even evolve into heart failure and preserved ejection fraction.
The expected aftermath of this study is :
- The estimation of the frequency of myocardial iron overload measured by 3 Tesla MRI in patient with HFE hereditary haemochromatosis;
- The assessment of its consequences on heart function;
- The appreciation of a cardiological assessment strategy in patients with HFE hereditary haemochromatosis.
- Being tested
- 3Tesla cardiac MRI, Electrocardiogram (EKG), Iron and cardiac markers, Pregnancy test, Echocardiography at rest
- Keywords
- myocardial iron overload, HFE-Associated Hereditary Hemochromatosis, 3 Tesla MRI, cardiological strategy in haemochromatosis, congestive heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3Tesla cardiac MRIDevice
Electrocardiogram (EKG)Device
Iron and cardiac markersBiological
Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP
Pregnancy testBiological
Beta-hCG
Echocardiography at restDevice
Transthoracic echocardiograph
Urinary pregnancy testBiological
3Tesla abdominal MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with HFE hereditary haemochromatosis | Experimental | The patients (40) will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions.
Then will be performed :
* An electrocardiogram
* Blood tests : iron and cardiac markers (serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP), beta-hCG if needed, serum bank
* A 3Tesla cardiac MRI repeated twice (in order to respect the reproducibility criterion)
* A 3Tesla abdominal MRI
* An echocardiography at rest. Receives: Device: 3Tesla cardiac MRI; Device: Electrocardiogram (EKG); Biological: Iron and cardiac markers; Biological: Pregnancy test; Device: Echocardiography at rest; Device: 3Tesla abdominal MRI |
| Healthy volunteers | Experimental | The healthy volunteers (10 men and 10 women) will undergo :
* A urinary pregnancy test (if applicable)
* A 3Tesla cardiac MRI repeated twice (in order to respect the reproducibility criterion)
* An echocardiography at rest. Receives: Device: 3Tesla cardiac MRI; Device: Echocardiography at rest; Biological: Urinary pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial T2* values in haemochromatosis compared to healthy volunteers
Assessment of the percentage rate of patients presenting a lower T2* value than the baseline defined by the mean of T2* values measured in healthy volunteers with a 1 standard deviation margin.
Measured: Day 1
Secondary outcomes (6)
Mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis
Comparison of the mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis
Measured: Day 1
Echocardiographic parameters of systolic and diastolic functions and myocardial deformation
Measured: Day 1
Myocardial T2 and T2* values in both groups
Measured: Day 1
Liver T2/T2* values
Correlation between liver T2/T2* and myocardial T2/T2*
Measured: Day 1
Pancreas T2/T2* values
Correlation between pancreas T2/T2* and myocardial T2/T2*
Measured: Day 1
Spleen T2/T2* values
Correlation between spleen T2/T2* and myocardial T2/T2*
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study start5 Nov 2014
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Iron OverloadStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erwan DONAL, MD, PhD, Principal investigator, Rennes University Hospital - Service de cardiologie et maladies vasculairesBruno LAVIOLLE, MD, PhD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099214
- Sponsor's protocol ID
- 2013-A01843-42
- Acronym
- HEMOCOEUR
- Status last verified
- Oct 2017
- First submitted
- 21 Mar 2014
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Myocardial Iron Overload by 3 Tesla MRI and Cardiac Functional Consequences in Patients With HFE Hereditary Haemochromatosis. Pilot Study
- ClinicalTrials.gov ID
- NCT02099214
- Acronym / sponsor ID
- HEMOCOEUR / 2013-A01843-42
- Keywords
- myocardial iron overload, HFE-Associated Hereditary Hemochromatosis, 3 Tesla MRI, cardiological strategy in haemochromatosis, congestive heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Nov 2014 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 28 Mar 2014 (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.
Hereditary haemochromatosis (HHC) is a frequent disease in Brittany (5 to 7‰), responsible first for biological disorder in blood iron parameters and minor clinical disorders, before evolving to potential life-threatening consequences such as diabetes, liver cirrhosis and congestive heart failure.
The improvement of screening and treatments made those severe affections rare enough not to evaluate myocardial iron overload a systematic part of the starting check-up. Nonetheless this myocardial iron overload might have severe implications on cardiac function on a long term basis.
A single trial was conducted on limited number of patients with 1.5 Tesla MRI, which showed a myocardial iron overload (defined by a myocardium T2* value <20ms) in 19% of the subjects.
The main objective of this study is to precisely estimate cardiac iron overload in treatment naive patients with newly diagnosed HFE hereditary haemochromatosis with a 3 Tesla MRI, more sensitive than the 1.5 Tesla one, in order to later appreciate its correlation with cardiac morbidity in HHC.
Detailed description
Since the wide use of phlebotomy was implemented the incidence of congestive heart failure in HHC became quite low. As such, the interest towards the initial diagnosis and cardiological follow-up has been lesser. A subclinical myocardial iron overload can nevertheless exist and eventually lead to functional consequences in the medium and long term if neglected, even evolve into heart failure and preserved ejection fraction.
The expected aftermath of this study is :
- The estimation of the frequency of myocardial iron overload measured by 3 Tesla MRI in patient with HFE hereditary haemochromatosis;
- The assessment of its consequences on heart function;
- The appreciation of a cardiological assessment strategy in patients with HFE hereditary haemochromatosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with HFE hereditary haemochromatosis | Experimental | Device: 3Tesla cardiac MRI, Device: Electrocardiogram (EKG), Biological: Iron and cardiac markers, Biological: Pregnancy test, Device: Echocardiography at rest, Device: 3Tesla abdominal MRIThe patients (40) will undergo a medical examination in order to analyse their medical history, cardiovascular parameters and check inclusion and non-inclusion criterions. Then will be performed : * An electrocardiogram * Blood tests : iron and cardiac markers (serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP), beta-hCG if needed, serum bank * A 3Tesla cardiac MRI repeated twice (in order to respect the reproducibility criterion) * A 3Tesla abdominal MRI * An echocardiography at rest. |
| Healthy volunteers | Experimental | Device: 3Tesla cardiac MRI, Device: Echocardiography at rest, Biological: Urinary pregnancy testThe healthy volunteers (10 men and 10 women) will undergo : * A urinary pregnancy test (if applicable) * A 3Tesla cardiac MRI repeated twice (in order to respect the reproducibility criterion) * An echocardiography at rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adults older than 18 ;
- Newly diagnosed with HFE hereditary haemochromatosis by genetic testing (homozygous for the C283Y mutation on HFE gene);
- Treatment-naive;
- Showing a ferritin level higher than 200µg/l for women and higher than 300µg/L for men;
- Affiliated to French Social Security;
Key exclusion criteria (25 listed)
- Cardiac pacemaker or implanted defibrillator ;
- Non MRI-compatible prosthetic cardiac valve;
- Non MRI-compatible clips/stents/coils/etc.;
- Cochlear implant;
- Peripheral or neuronal stimulator;
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 |
|---|---|---|
| 3Tesla cardiac MRI | Device | Healthy volunteers, Patients with HFE hereditary haemochromatosis |
| Electrocardiogram (EKG) | Device | Patients with HFE hereditary haemochromatosis |
| Iron and cardiac markersSerum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP | Biological | Patients with HFE hereditary haemochromatosis |
| Pregnancy testBeta-hCG | Biological | Patients with HFE hereditary haemochromatosis |
| Echocardiography at restTransthoracic echocardiograph | Device | Healthy volunteers, Patients with HFE hereditary haemochromatosis |
| Urinary pregnancy test | Biological | Healthy volunteers |
| 3Tesla abdominal MRI | Device | Patients with HFE hereditary haemochromatosis |
Primary outcome
Myocardial T2* values in haemochromatosis compared to healthy volunteers
Time frame: Day 1
Assessment of the percentage rate of patients presenting a lower T2* value than the baseline defined by the mean of T2* values measured in healthy volunteers with a 1 standard deviation margin.
6 secondary outcomes
Mean T2 values in healthy volunteers and patients with HFE-related haemochromatosis
Time frame: Day 1
Echocardiographic parameters of systolic and diastolic functions and myocardial deformation
Time frame: Day 1
Myocardial T2 and T2* values in both groups
Time frame: Day 1
Liver T2/T2* values
Time frame: Day 1
Pancreas T2/T2* values
Time frame: Day 1
Spleen T2/T2* values
Time frame: Day 1
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 Oct 2017.
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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.
Erwan DONAL, MD, PhD principal investigator
Rennes University Hospital - Service de cardiologie et maladies vasculaires
Bruno LAVIOLLE, MD, PhD study chair
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3Tesla cardiac MRI, Electrocardiogram (EKG) and Iron and cardiac markers in people with Myocardial Iron Overload and HFE-Associated Hereditary Hemochromatosis, run by Rennes University Hospital at 1 site in France.
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 15 inclusion and 25 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 Oct 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 France. 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 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?
Myocardial T2* values in haemochromatosis compared to healthy volunteers (time frame: Day 1). 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 20 Oct 2017.