Heart FailurePhase 2Metamod3NCT01192373
Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"
A Phase 2 study testing Metabolic substrate modulation in people with Heart Failure and Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes. Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Heart Failure, Diabetes
- What is being tested?
- Metabolic substrate modulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 2
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ejection fraction at or lower than 45%
- type 2 diabetes
Who cannot join
- known s-creatinine >220mM
- known S-alanine aminotransferase >3 times normal upper limit
- other disabilitating conditions
- pregnancy
- insulin treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of cardiology, Aarhus University hospital Skejby,
Aarhus, Region Midjylland, 8200
About this study
Official title: Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: "Effect on Myocardial Lipid Content, Left Ventricular Function and Exercise Capacity"
The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes.
Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.
- Conditions
- Heart Failure, Diabetes
- Being tested
- Metabolic substrate modulation
- Medical subject headings
- Heart Failure, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic substrate modulationOther
for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
metabolic substrate modulationOther
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
| Study group | Role | What they receive |
|---|---|---|
| High circulating free fatty acids | Experimental | using Heparin af intralipid infusion for 8 hours Receives: Other: Metabolic substrate modulation |
| Low circulation free fatty acids | Active comparator | using hyperinsulinaemic euglycemic clamp for 8 hours Receives: Other: metabolic substrate modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular function
Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate).
Left ventricular diastolic funtion (E/A ratio, E/e' ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids.
Measured: 1-6 weeks
intracellular lipid content
Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content).
Outcome is difference between low and high ciculating free fatty acids.
Measured: 1-6 weeks
Exercise capacity and oxygen consumption
Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.
Measured: 1-6 weeks
Secondary outcomes (3)
Regional left ventricular function
regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids.
Measured: 1-6 weeks
6 minutes hall walk test
distance difference between low and high levels of circulating FFA. Outcome is difference between low and high ciculating free fatty acids.
Measured: 1-6 weeks
metabolic and hormonal profile
bloodsamples
Measured: 1-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Roni R Nielsen, MD, Principal investigator, Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192373
- Sponsor's protocol ID
- M20090230
- Acronym
- Metamod3
- Status last verified
- Jan 2013
- First submitted
- 24 Aug 2010
- Last updated
- 21 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen R, Norrelund H, Kampmann U, Kim WY, Ringgaard S, Schar M, Moller N, Botker HE, Wiggers H. Failing heart of patients with type 2 diabetes mellitus can adapt to extreme short-term increases in circulating lipids and does not display features of acute myocardial lipotoxicity. Circ Heart Fail. 2013 Jul;6(4):845-52. doi: 10.1161/CIRCHEARTFAILURE.113.000187. Epub 2013 Jun 3.
PubMed 23733915
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: "Effect on Myocardial Lipid Content, Left Ventricular Function and Exercise Capacity"
- ClinicalTrials.gov ID
- NCT01192373
- Acronym / sponsor ID
- Metamod3 / M20090230
- Conditions
- Heart Failure, Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 1 Sep 2010 (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.
The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes.
Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High circulating free fatty acids | Experimental | Other: Metabolic substrate modulationusing Heparin af intralipid infusion for 8 hours |
| Low circulation free fatty acids | Active comparator | Other: metabolic substrate modulationusing hyperinsulinaemic euglycemic clamp for 8 hours |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ejection fraction at or lower than 45%
- type 2 diabetes
Key exclusion criteria (5 listed)
- known s-creatinine >220mM
- known S-alanine aminotransferase >3 times normal upper limit
- other disabilitating conditions
- pregnancy
- insulin treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic substrate modulationfor high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour). | Other | High circulating free fatty acids |
| metabolic substrate modulationlow circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM. | Other | Low circulation free fatty acids |
Primary outcome
Left ventricular function
Time frame: 1-6 weeks
Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate). Left ventricular diastolic funtion (E/A ratio, E/e' ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids.
intracellular lipid content
Time frame: 1-6 weeks
Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content). Outcome is difference between low and high ciculating free fatty acids.
Exercise capacity and oxygen consumption
Time frame: 1-6 weeks
Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.
3 secondary outcomes
Regional left ventricular function
Time frame: 1-6 weeks
6 minutes hall walk test
Time frame: 1-6 weeks
metabolic and hormonal profile
Time frame: 1-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Derived from this study: PubMed 23733915Nielsen R, Norrelund H, Kampmann U, Kim WY, Ringgaard S, Schar M, Moller N, Botker HE, Wiggers H. Failing heart of patients with type 2 diabetes mellitus can adapt to extreme short-term increases in circulating lipids and does not display features of acute myocardial lipotoxicity. Circ Heart Fail. 2013 Jul;6(4):845-52. doi: 10.1161/CIRCHEARTFAILURE.113.000187. Epub 2013 Jun 3.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Roni R Nielsen, MD principal investigator
Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metabolic substrate modulation in people with Heart Failure and Diabetes, run by University of Aarhus at 1 site in Denmark.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jan 2013. 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 Denmark. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left ventricular function (time frame: 1-6 weeks). The study lists 3 primary outcomes in all. 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 NCT01192373, which also lists 1 linked publication.
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 21 Jan 2013.