Myocardial Metabolism in Patients With Dilated Cardiomyopathy

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      other pairs of arterial and venous samples are withdrawn.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.

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

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