Patients With Idiopathic Dilated CardiomyopathyNCT02078141
18F-deoxyglucose (FDG) PET-CMD
A study testing 18F-deoxyglucose (FDG) in people with Patients With Idiopathic Dilated Cardiomyopathy, run by Nantes University Hospital at 2 sites in France.
Trial summary
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a promising tool for identification of myocardial inflammation in patients with dilated cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the fixation of FDG in non cardiomyocyte cells in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Idiopathic Dilated Cardiomyopathy
- What is being tested?
- 18F-deoxyglucose (FDG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Jun 2014to 18 Jan 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years of age
- Patients with DCM as defined by the European Society of Cardiology and recognized as such by the clinician cardiologist
- DCM diagnosed for more than two weeks without new ventricular arrhythmias or AuriculoVentricular Block (AVB) second or third degree , who responded to the usual treatment in the first two weeks of treatment
- No family history of DCM
- Lake of clinical or biological cases for periphiral myopathy or myotonia
- Absence of other causes of non-family DCM discovered during the initial etiological ( some deficiency , toxic alcoholic or drug )
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- Patients who underwent cardiac MRI for etiological DCM for less than four weeks at the time of obtaining consent
- Patients who have read and understood the information letter and who signed the consent form
- Affiliated to a social insurance
Who cannot join
- Ischemic cardiomyopathy defined by history of myocardial infarction or myocardial revascularization , stenosis ≥ 75% of the core or the left coronary artery anterior interventricular proximal stenosis ≥ 75% on at least two epicardial vessels
- Significant organic valvular echocardiography
- Eosinophilia or immuno- allergic mechanism suspected
- History of acute myocarditis
- History of sarcoidosis
- Family history of DCM
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- History of chemotherapy with anthracyclines
- Patient with signs of circulatory failure or congestive heart failure requiring intravenous positive inotropic therapy or diuretic therapy
- Treatment immunosuppressive received from cardiac MRI
- Hypersensitivity to heparin.
- History of severe thrombocytopenia type II ( heparin induced thrombocytopenia or immuno- allergic thrombocytopenia ) , heparin or unfractionated heparin , low molecular weight
- Other causes of non-family DCM discovered during the initial etiological ( some deficiency , toxic alcohol or medication , endocrine )
- Patients with active neoplasia
- Patients with chronic liver disease
- Patients with connective : rheumatoid arthritis , systemic lupus erythematosus , systemic sclerosis , dermato- polymyositis , mixed connective
- Patients with Crohn's disease
- Patients with active tuberculosis
- Pregnant or lactating women
- Minors
- Major Trust
- No affiliation to a social insurance
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes UH
Nantes, 44903
West Cancerology Institute/Nantes UH : PET plateform
Saint-Herblain, 44805
About this study
Official title: Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a promising tool for identification of myocardial inflammation in patients with dilated cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the frequency and describe the different binding profiles in comparison with MRI data.
Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.
Read more
All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A high fat and low carbohydrate diet and an heparin injection will be prescribed to patients before this FDG PET.
Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be completed by a 12 months evaluation.
- Being tested
- 18F-deoxyglucose (FDG)
- Keywords
- 18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-deoxyglucose (FDG)Drug
18F-deoxyglucose (FDG) One injection of 3.5 MBq/kg of 18FDG with a minimum of 220 MBq and a maximum of 400 MBq
| Study group | Role | What they receive |
|---|---|---|
| 18F-deoxyglucose (FDG) | Experimental | 18F-deoxyglucose (FDG) Receives: Drug: 18F-deoxyglucose (FDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism
We want to objective a significant hypermetabolic extra-cardiomyocyte by 18F-FDG PET examination, in favor of myocardial inflammation in patients with DCM diagnosed for more than two weeks without new ventricular arrhythmias or second AVB or third degree, and who responded to the usual treatment in the first two weeks of treatment.
Measured: 12 months
Secondary outcomes (4)
Comparison of clinical, biology, and left and ventricular remodeling at the time of diagnosis of DCM between the group of patients with significative myocardial no cardiomyocytaire uptake (FDG +) and those with no uptake (FDG -)
Measured: 12 months
Evaluate the performance of 18F-FDG PET for the detection of myocardial inflammation in the initial evaluation of DCM patients compared to cardiac MRI
Measured: 12 months
Describe the different profile of FDG fixation within the group of patients FDG +
Measured: 12 months
impact of the presence or absence of a non-cardiomyocyte uptake of 18F-FDG PET at diagnosis of DCM in regard to the clinical status, ultrasound and MRI results
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study start24 Jun 2014
- Primary completion18 Jan 2018
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Idiopathic Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Nantes 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Piriou, MD, Principal investigator, Nantes UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078141
- Sponsor's protocol ID
- RC14_0002
- Status last verified
- Jul 2022
- First submitted
- 21 Feb 2014
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.
- ClinicalTrials.gov ID
- NCT02078141
- Acronym / sponsor ID
- RC14_0002
- Keywords
- 18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 24 Jun 2014 (actual)
- Primary completion
- 18 Jan 2018 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 5 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.
18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) may have application in a promising tool for identification of myocardial inflammation in patients with dilated cardiomyopathy (DCM).Therefore, the purpose of the study is to confirm the hypothesis of the fixation of FDG in non cardiomyocyte cells in a number of patients with DCM, to specify the frequency and describe the different binding profiles in comparison with MRI data.
Patients will perform an ethologic evaluation of a non ischemic DCM with in a cardiac MRI.
All patients will have with in 4 weeks after the MRI a 18F-fluorodeoxyglucose (FDG) PET. A high fat and low carbohydrate diet and an heparin injection will be prescribed to patients before this FDG PET.
Patients will be identified as FDG+ or FDG -. The clinical status of the patient will be completed by a 12 months evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-deoxyglucose (FDG) | Experimental | Drug: 18F-deoxyglucose (FDG)18F-deoxyglucose (FDG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients above 18 years of age
- Patients with DCM as defined by the European Society of Cardiology and recognized as such by the clinician cardiologist
- DCM diagnosed for more than two weeks without new ventricular arrhythmias or AuriculoVentricular Block (AVB) second or third degree , who responded to the usual treatment in the first two weeks of treatment
- No family history of DCM
- Lake of clinical or biological cases for periphiral myopathy or myotonia
Key exclusion criteria (21 listed)
- Ischemic cardiomyopathy defined by history of myocardial infarction or myocardial revascularization , stenosis ≥ 75% of the core or the left coronary artery anterior interventricular proximal stenosis ≥ 75% on at least two epicardial vessels
- Significant organic valvular echocardiography
- Eosinophilia or immuno- allergic mechanism suspected
- History of acute myocarditis
- History of sarcoidosis
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 |
|---|---|---|
| 18F-deoxyglucose (FDG)18F-deoxyglucose (FDG) One injection of 3.5 MBq/kg of 18FDG with a minimum of 220 MBq and a maximum of 400 MBq | Drug | 18F-deoxyglucose (FDG) |
Primary outcome
Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism
Time frame: 12 months
We want to objective a significant hypermetabolic extra-cardiomyocyte by 18F-FDG PET examination, in favor of myocardial inflammation in patients with DCM diagnosed for more than two weeks without new ventricular arrhythmias or second AVB or third degree, and who responded to the usual treatment in the first two weeks of treatment.
4 secondary outcomes
Comparison of clinical, biology, and left and ventricular remodeling at the time of diagnosis of DCM between the group of patients with significative myocardial no cardiomyocytaire uptake (FDG +) and those with no uptake (FDG -)
Time frame: 12 months
Evaluate the performance of 18F-FDG PET for the detection of myocardial inflammation in the initial evaluation of DCM patients compared to cardiac MRI
Time frame: 12 months
Describe the different profile of FDG fixation within the group of patients FDG +
Time frame: 12 months
impact of the presence or absence of a non-cardiomyocyte uptake of 18F-FDG PET at diagnosis of DCM in regard to the clinical status, ultrasound and MRI results
Time frame: 12 months
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 26 Jul 2022.
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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.
Nicolas Piriou, MD principal investigator
Nantes UH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-deoxyglucose (FDG) in people with Patients With Idiopathic Dilated Cardiomyopathy, run by Nantes University Hospital at 2 sites 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 9 inclusion and 21 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 26 Jul 2022. 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 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?
Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism (time frame: 12 months). 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 26 Jul 2022.