Myocardial Metabolism in Patients With Dilated Cardiomyopathy

Type 2 Diabetes Clinical Trial

Official title:

Abnormal Glucose Tolerance is Associated With a Reduced Myocardial Metabolic Flexibility in Patients With Dilated Cardiomyopathy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02440217
• Other study ID #: CardMet
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 6, 2015
• Last updated: May 7, 2015
• Start date: May 2015
• Est. completion date: June 2015

Study information

• Verified date: May 2015
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 69 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Type 2 Diabetes

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa	PI

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. Epub 2007 Oct 5. — View Citation

Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial metabolic responses to stress in humans	The investigators aimed at evaluating myocardial NEFA and glucose uptake.	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).	No