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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
Sponsor:
Information provided by (Responsible Party):
Andrea Natali, 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).

Condition or disease
Dilated Cardiomyopathy Type 2 Diabetes

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is then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.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
Estimated Enrollment : 15 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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


Group/Cohort
DCM-AGT
Subjects with both dilated cardiomyopathy (DCM) and abnormal glucose tolerance (AGT, either impaired glucose tolerance or type 2 diabetes).
DCM-NGT
Subjects with dilated cardiomyopathy (DCM) and normal glucose tolerance (NGT).
N-AGT
Subjects without dilated cardiomyopathy (N) with abnormal glucose tolerance (AGT, either impaired glucose tolerance or type 2 diabetes).



Primary Outcome Measures :
  1. 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
Serum, whole blood


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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiology Department of the Institute of Clinical physiology
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440217


Locations
Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, Italy, 56127
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
Investigators
Study Chair: Andrea Natali, Professor Azienda Ospedaliero, Universitaria Pisana