Myocardial Metabolism in Patients With Dilated Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT02440217|
Recruitment Status : Unknown
Verified May 2015 by Andrea Natali, Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was: Enrolling by invitation
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
|Condition or disease|
|Dilated Cardiomyopathy Type 2 Diabetes|
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is then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.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|
|Estimated Enrollment :||15 participants|
|Observational Model:||Case Control|
|Official Title:||Abnormal Glucose Tolerance is Associated With a Reduced Myocardial Metabolic Flexibility in Patients With Dilated Cardiomyopathy|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
Subjects with both dilated cardiomyopathy (DCM) and abnormal glucose tolerance (AGT, either impaired glucose tolerance or type 2 diabetes).
Subjects with dilated cardiomyopathy (DCM) and normal glucose tolerance (NGT).
Subjects without dilated cardiomyopathy (N) with abnormal glucose tolerance (AGT, either impaired glucose tolerance or type 2 diabetes).
- Myocardial metabolic responses to stress in humans [ Time Frame: Arterio-venous sampling will be performed in about an hour during three experimental condition: rest (time -15 and 0 min), pacing (3 and 6 min), and recovery (1, 5, 15 and 30 min). ]The investigators aimed at evaluating myocardial NEFA and glucose uptake.
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440217
|Azienda Ospedaliero-Universitaria Pisana|
|Pisa, PI, Italy, 56127|
|Study Chair:||Andrea Natali, Professor||Azienda Ospedaliero, Universitaria Pisana|