Dilated CardiomyopathyNCT02440217
Myocardial Metabolism in Patients With Dilated Cardiomyopathy
An observational study of Dilated Cardiomyopathy and Type 2 Diabetes, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Dilated Cardiomyopathy, Type 2 Diabetes
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiology Department of the Institute of Clinical physiology
Who may be able to join
- 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.
Who cannot join
- NYHA class IV
- Atrial fibrillation
- Previous myocardial infarction
- Valvular heart disease
- Myocarditis
- Pericarditis
Show all 9Show fewer
- Severe to moderate systemic arterial hypertension
- Fasting hyperglycaemia (>7.0 mmol/l)
- Treated diabetes, autoimmune diseases, neoplasia, kidney, liver or respiratory failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Dilated Cardiomyopathy, Type 2 Diabetes
- Medical subject headings
- Cardiomyopathy, Dilated, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Myocardial metabolic responses to stress in humans
The investigators aimed at evaluating myocardial NEFA and glucose uptake.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natali, Azienda Ospedaliero, Universitaria Pisana
- Investigators
- Andrea Natali, Professor, Study chair, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440217
- Sponsor's protocol ID
- CardMet
- Status last verified
- May 2015
- First submitted
- 6 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15987803Neglia 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.
PubMed 17921325Trico 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.
PubMed 26798650
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abnormal Glucose Tolerance is Associated With a Reduced Myocardial Metabolic Flexibility in Patients With Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02440217
- Acronym / sponsor ID
- CardMet
- Conditions
- Dilated Cardiomyopathy, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology Department of the Institute of Clinical physiology
Key inclusion criteria (6 listed)
- Myocardial left ventricular ejection fraction (LVEF) <40%
- left ventricular end-diastolic diameter (LVEDD) >56 mm
- LVEF >50%
- LVEDD <56 mm.
Key exclusion criteria (9 listed)
- NYHA class IV
- Atrial fibrillation
- Previous myocardial infarction
- Valvular heart disease
- Myocarditis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Background: PubMed 15987803Stanley 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.
- Background: PubMed 17921325Neglia 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.
- Derived from this study: PubMed 26798650Trico 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Natali, Professor study chair
Azienda Ospedaliero, Universitaria Pisana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy and Type 2 Diabetes, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02440217, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2015.