Clinical trial NCT02440217: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dilated Cardiomyopathy
Type 2 Diabetes
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology Department of the Institute of Clinical physiology

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is then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.

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

Primary outcomes:
measure: Myocardial metabolic responses to stress in humans
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Andrea Natali, Professor
role: STUDY_CHAIR
References:
citation: Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. doi: 10.1152/physrev.00006.2004.
citation: Neglia D, De Caterina A, Marraccini P, Natali A, Ciardetti M, Vecoli C, Gastaldelli A, Ciociaro D, Pellegrini P, Testa R, Menichetti L, L'Abbate A, Stanley WC, Recchia FA. Impaired myocardial metabolic reserve and substrate selection flexibility during stress in patients with idiopathic dilated cardiomyopathy. Am J Physiol Heart Circ Physiol. 2007 Dec;293(6):H3270-8. doi: 10.1152/ajpheart.00887.2007. Epub 2007 Oct 5.
citation: Trico D, Baldi S, Frascerra S, Venturi E, Marraccini P, Neglia D, Natali A. Abnormal Glucose Tolerance Is Associated with a Reduced Myocardial Metabolic Flexibility in Patients with Dilated Cardiomyopathy. J Diabetes Res. 2016;2016:3906425. doi: 10.1155/2016/3906425. Epub 2015 Dec 21.