Myocardial Metabolism in Patients With Dilated Cardiomyopathy

NCT ID: NCT02440217

Last Updated: 2015-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-06-30

Brief Summary

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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

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then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.

Conditions

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Dilated Cardiomyopathy Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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DCM-AGT

Subjects with both dilated cardiomyopathy (DCM) and abnormal glucose tolerance (AGT, either impaired glucose tolerance or type 2 diabetes).

No interventions assigned to this group

DCM-NGT

Subjects with dilated cardiomyopathy (DCM) and normal glucose tolerance (NGT).

No interventions assigned to this group

N-AGT

Subjects without dilated cardiomyopathy (N) with abnormal glucose tolerance (AGT, either impaired glucose tolerance or type 2 diabetes).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role lead

Responsible Party

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Andrea Natali

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Natali, Professor

Role: STUDY_CHAIR

Azienda Ospedaliero, Universitaria Pisana

Locations

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Azienda Ospedaliero-Universitaria Pisana

Pisa, PI, Italy

Site Status

Countries

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Italy

References

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Stanley WC, Recchia FA, Lopaschuk GD. Myocardial substrate metabolism in the normal and failing heart. Physiol Rev. 2005 Jul;85(3):1093-129. doi: 10.1152/physrev.00006.2004.

Reference Type BACKGROUND
PMID: 15987803 (View on PubMed)

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. doi: 10.1152/ajpheart.00887.2007. Epub 2007 Oct 5.

Reference Type BACKGROUND
PMID: 17921325 (View on PubMed)

Trico D, Baldi S, Frascerra S, Venturi E, Marraccini P, Neglia D, Natali A. Abnormal Glucose Tolerance Is Associated with a Reduced Myocardial Metabolic Flexibility in Patients with Dilated Cardiomyopathy. J Diabetes Res. 2016;2016:3906425. doi: 10.1155/2016/3906425. Epub 2015 Dec 21.

Reference Type DERIVED
PMID: 26798650 (View on PubMed)

Other Identifiers

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CardMet

Identifier Type: -

Identifier Source: org_study_id

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