Clinical trial NCT02078141: 18F-deoxyglucose (FDG) PET-CMD
Official title: Monocentric, Prospective, Uncontrolled Pilot Study of Extra Cardiomyocytary Fixation Profile in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography in Patients With Dilated Cardiomyopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Idiopathic Dilated Cardiomyopathy
Keywords: 18F-deoxyglucose (FDG) PET, idiopathic Dilated Cardiomyopathy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Determine the percentage of patients with a diagnostic potential of the 18F-FDG PET in the detection of a significant non-cardiomyocyte hypermetabolism
timeFrame: 12 months
Secondary outcomes:
measure: 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 -)
timeFrame: 12 months
measure: Evaluate the performance of 18F-FDG PET for the detection of myocardial inflammation in the initial evaluation of DCM patients compared to cardiac MRI
timeFrame: 12 months
measure: Describe the different profile of FDG fixation within the group of patients FDG +
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes UH
city: Saint Herblain
country: France
facility: West Cancerology Institute/Nantes UH : PET plateform
Study officials:
affiliation: Nantes UH
name: Nicolas Piriou, MD
role: PRINCIPAL_INVESTIGATOR
References: