Myocardial Metabolism in Patients With Dilated Cardiomyopathy

• Conditions: Type 2 Diabetes; Dilated Cardiomyopathy

• Registration Number: NCT02440217
• Lead Sponsor: Azienda Ospedaliero, Universitaria Pisana

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then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.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

• Status Verified: 2015-05
• Study Start: 2015-05
• Study First Submitted: 2015-05-06
• Study First Submitted QC: 2015-05-07
• Last Update Submitted: 2015-05-07
• Study First Posted: 2015-05-12
• Last Update Posted: 2015-05-12
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial metabolic responses to stress in humans	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.

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, PI, Italy