Myocardial Metabolism in Patients With Dilated Cardiomyopathy

May 7, 2015 updated by: Andrea Natali, Azienda Ospedaliero, Universitaria Pisana

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

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).

Study Overview

Status

Unknown

Conditions

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then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.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

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • PI
      • Pisa, PI, Italy, 56127
        • Azienda Ospedaliero-Universitaria Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiology Department of the Institute of Clinical physiology

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Investigators

  • Study Chair: Andrea Natali, Professor, Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

May 6, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CardMet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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