Brief Title
Myocardial Metabolism in Patients With Dilated Cardiomyopathy
Official Title
Abnormal Glucose Tolerance is Associated With a Reduced Myocardial Metabolic Flexibility in Patients With Dilated Cardiomyopathy
Brief Summary
Dilated cardiomyopathy (DCM) is characterized by a metabolic shift from fat to carbohydrates and failure to increase myocardial glucose uptake in response to workload increments. The investigators aimed at verifying whether this pattern is influenced by the presence of abnormal glucose tolerance (AGT).
Detailed Description
A catheter is advanced into the coronary sinus by fluoroscopy to withdraw venous blood. A unipolar pacing catheter is positioned into the right atrium. Arterial sampling is done from the femoral artery introducer catheter. The study protocol consisted of 3 steps (Rest, Pacing and Recovery), during which timed blood samples are collected to measure plasma NEFA and glucose. After the instrumentation is completed, Rest arterio-venous sampling is performed at time -15 min and 0 min. After the 0 min, heart rate is increased by atrial pacing to 110 bpm for 3 minutes and to 130 bpm for 3 additional minutes and arterio-venous sampling is repeated at the end of each step (at time 3 and 6 min). Pacing is then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.
Study Type
Observational
Primary Outcome
Myocardial metabolic responses to stress in humans
Condition
Dilated Cardiomyopathy
Study Arms / Comparison Groups
DCM-AGT
Description: Subjects with both dilated cardiomyopathy (DCM) and abnormal glucose tolerance (AGT, either impaired glucose tolerance or type 2 diabetes).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
15
Start Date
May 2015
Completion Date
June 2015
Primary Completion Date
June 2015
Eligibility Criteria
Inclusion Criteria: For patients with dilated cardiomyopathy: - Myocardial left ventricular ejection fraction (LVEF) <40% - left ventricular end-diastolic diameter (LVEDD) >56 mm For patients without dilated cardiomyopathy: - LVEF >50% - LVEDD <56 mm. Exclusion Criteria: - NYHA class IV - Atrial fibrillation - Previous myocardial infarction - Valvular heart disease - Myocarditis - Pericarditis - Severe to moderate systemic arterial hypertension - Fasting hyperglycaemia (>7.0 mmol/l) - Treated diabetes, autoimmune diseases, neoplasia, kidney, liver or respiratory failure
Gender
All
Ages
21 Years - 69 Years
Accepts Healthy Volunteers
No
Contacts
Andrea Natali, Professor, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT02440217
Organization ID
CardMet
Responsible Party
Principal Investigator
Study Sponsor
Azienda Ospedaliero, Universitaria Pisana
Study Sponsor
Andrea Natali, Professor, Study Chair, Azienda Ospedaliero, Universitaria Pisana
Verification Date
May 2015