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CompletedNCT02078141Updated Jul 26, 2022

18F-deoxyglucose (FDG) PET-CMD

An interventional study of 18F-deoxyglucose (FDG) in Patients With Idiopathic Dilated Cardiomyopathy, sponsored by Nantes University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

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Conditions studied

  • Patients With Idiopathic Dilated Cardiomyopathy

Keywords

  • 18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy
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In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 30 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 )
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    18F-deoxyglucose (FDG)

    18F-deoxyglucose (FDG)

    Drug: 18F-deoxyglucose (FDG)

Interventions

  • Drug18F-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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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

  2. 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

  3. Describe the different profile of FDG fixation within the group of patients FDG +

    Time frame: 12 months

  4. 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

07

Study locations

2 sites
  • Nantes UH
    Nantes, 44903, France
  • West Cancerology Institute/Nantes UH : PET plateform
    Saint Herblain, 44805, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02078141
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Mar 5, 2014
Start date
Jun 24, 2014
Primary completion
Jan 18, 2018
Completion
Jan 18, 2018
Last update
Jul 26, 2022

Study contacts

Nicolas Piriou, MD
principal investigator · Nantes UH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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