Ischemic Heart DiseaseNCT06054516
Hyperpolarized MRSI in Ischemic Heart Disease: A Metabolic Investigation of the Heart Muscle
An observational study of Ischemic Heart Disease, run by Henrik Wiggers at 1 site in Denmark.
Trial summary
This study aims to investigate the potential of using hyperpolarized [1-13C]-pyruvate magnetic resonance imaging (MRI) to assess metabolic alterations in patients with ischemic heart disease (IHD). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- 13C-enriched pyruvate
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Oct 2023to 31 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic heart disease treated at Aarhus University Hospital
Who may be able to join
- Chronic heart failure
- >18 years of age
- Left ventricular Ejection Fraction (LVEF) of 10 - 60 %
- Adequate hematologic and organ function.
- Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study.
- Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted.
Show all 10Show fewer
- Non-insulin dependent Diabetes mellitus is allowed
- Danish speaking
- Able and willing to comply after informed consent
- Ischemic heart disease and referral to viability testing at the Department of Clinical Physiology and Nuclear Medicine at Aarhus University Hospital.
Who cannot join
- Not able or willing to receive heart failure therapy
- Patients not willing to participate
- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia
- Estimated Glomerular Filtration Rate (eGFR) <30 mL/min
- Insulin dependent Diabetes Mellitus
- Intolerance to Pyruvate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Niels A. Jespersen, MD, +4522950990, nijesp@rm.dk
Henrik Wiggers, Professor, +4522753202, henrik.wiggers@dadlnet.dk
About this study
Official title: Hyperpolarized MRSI in Ischemic Heart Disease: Metabolic Profiling of the Myocardium
This study aims to investigate the potential of using hyperpolarized [1-13C]-pyruvate magnetic resonance imaging (MRI) to assess metabolic alterations in patients with ischemic heart disease (IHD). Altered myocardial metabolism is recognized as a crucial factor in heart failure and IHD, and modulating cardiac metabolism offers a new approach to treatment. However, current diagnostic modalities use ionizing radiation and have shown limited prognostic value.
Hyperpolarization through dynamic nuclear polarization (DNP) enables highly sensitive in vivo detection of metabolic processes. Hyperpolarized [1-13C]-pyruvate allows visualization of glycolysis-related metabolism, providing insights into the breakdown of glucose and its derivatives. By using this technique, the study aims to differentiate viable from non-viable myocardium in patients with IHD.
Read more
The objectives include implementing hyperpolarized [1-13C]-pyruvate cardiac MRI to image metabolic flux in the human heart and investigating the potential of this method to distinguish viable from non-viable myocardium in patients with IHD. The study endpoints involve assessing metabolic flux through the pyruvate dehydrogenase complex (PDC) and analyzing ratios of different metabolites, which can indicate the extent of pyruvate oxidation and lactate production.
A cross-sectional study design involving patients with CHF and ischemic heart disease will be used. Patients will undergo hyperpolarized [1-13C]-pyruvate MRI, PET imaging, late gadolinium enhancement (LGE) MRI, and cardiac magnetic resonance imaging (CMR). The study will compare [1-13C]-pyruvate MRI findings with PET results, allowing for a correlation between metabolic data and traditional imaging techniques. This innovative approach could provide valuable insights into the metabolic changes associated with ischemic heart disease
- Conditions
- Ischemic Heart Disease
- Being tested
- 13C-enriched pyruvate
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-enriched pyruvateDiagnostic test
Before starting the hyperpolarization injection procedure, the patient will be scanned using the standard MR imaging defined in the clinical protocol and 13C prescriptions and a pre-scan will be completed. The clinical investigator will mount the administration syringe in the MR compatible power-injector with pre-adjusted injection volume calculated according to body weight (0.43 ml /kg bw). This setting is checked by the scanning operator and clinical investigator. The injection valve is set for agent delivery, and agent injected at a rate of 5 ml/s. The timings are monitored using a stopwatch on the SPINLAB. Following injection of hyperpolarized [1-13C]-Pyruvate , 20 ml of sterile saline in a separate syringe, already attached to the patient line, will be used to flush the IV line at the same injection rate (5 ml/s).
| Study group | Role | What they receive |
|---|---|---|
| Ischemic heart disease | Not described Receives: Diagnostic Test: 13C-enriched pyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative numerical data given as metabolite ratios
[13C]-bicarbonate/[1-13C]-pyruvate ratio, b) [1-13C]-lactate / [1-13C]-pyruvate ratio and [1-13C]-lactate / [1-13C]-bicarbonate ratio. The latter gives ratio indices of PDC-mediated pyruvate oxidation and lactate production via lactate dehydrogenase.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start13 Oct 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Wiggers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Wiggers, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054516
- Sponsor's protocol ID
- 65424
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Neubauer S. The failing heart--an engine out of fuel. N Engl J Med. 2007 Mar 15;356(11):1140-51. doi: 10.1056/NEJMra063052. No abstract available.
PubMed 17360992Rider OJ, Tyler DJ. Clinical implications of cardiac hyperpolarized magnetic resonance imaging. J Cardiovasc Magn Reson. 2013 Oct 8;15(1):93. doi: 10.1186/1532-429X-15-93.
PubMed 24103786Ardenkjaer-Larsen JH, Fridlund B, Gram A, Hansson G, Hansson L, Lerche MH, Servin R, Thaning M, Golman K. Increase in signal-to-noise ratio of > 10,000 times in liquid-state NMR. Proc Natl Acad Sci U S A. 2003 Sep 2;100(18):10158-63. doi: 10.1073/pnas.1733835100. Epub 2003 Aug 20.
PubMed 12930897Golman K, Petersson JS, Magnusson P, Johansson E, Akeson P, Chai CM, Hansson G, Mansson S. Cardiac metabolism measured noninvasively by hyperpolarized 13C MRI. Magn Reson Med. 2008 May;59(5):1005-13. doi: 10.1002/mrm.21460.
PubMed 18429038Schroeder MA, Lau AZ, Chen AP, Gu Y, Nagendran J, Barry J, Hu X, Dyck JR, Tyler DJ, Clarke K, Connelly KA, Wright GA, Cunningham CH. Hyperpolarized (13)C magnetic resonance reveals early- and late-onset changes to in vivo pyruvate metabolism in the failing heart. Eur J Heart Fail. 2013 Feb;15(2):130-40. doi: 10.1093/eurjhf/hfs192. Epub 2012 Dec 19.
PubMed 23258802Cunningham CH, Lau JY, Chen AP, Geraghty BJ, Perks WJ, Roifman I, Wright GA, Connelly KA. Hyperpolarized 13C Metabolic MRI of the Human Heart: Initial Experience. Circ Res. 2016 Nov 11;119(11):1177-1182. doi: 10.1161/CIRCRESAHA.116.309769. Epub 2016 Sep 15.
PubMed 27635086Hansen ESS, Tougaard RS, Norlinger TS, Mikkelsen E, Nielsen PM, Bertelsen LB, Botker HE, Jorgensen HS, Laustsen C. Imaging porcine cardiac substrate selection modulations by glucose, insulin and potassium intervention: A hyperpolarized [1-13 C]pyruvate study. NMR Biomed. 2017 Jun;30(6). doi: 10.1002/nbm.3702. Epub 2017 Feb 10.
PubMed 28186677Apps A, Lau JYC, Miller JJJJ, Tyler A, Young LAJ, Lewis AJM, Barnes G, Trumper C, Neubauer S, Rider OJ, Tyler DJ. Proof-of-Principle Demonstration of Direct Metabolic Imaging Following Myocardial Infarction Using Hyperpolarized 13C CMR. JACC Cardiovasc Imaging. 2021 Jun;14(6):1285-1288. doi: 10.1016/j.jcmg.2020.12.023. Epub 2021 Feb 10. No abstract available.
PubMed 33582059
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperpolarized MRSI in Ischemic Heart Disease: Metabolic Profiling of the Myocardium
- ClinicalTrials.gov ID
- NCT06054516
- Acronym / sponsor ID
- 65424
- Conditions
- Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Henrik WiggersUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Sep 2023 (actual)
- 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.
This study aims to investigate the potential of using hyperpolarized [1-13C]-pyruvate magnetic resonance imaging (MRI) to assess metabolic alterations in patients with ischemic heart disease (IHD). Altered myocardial metabolism is recognized as a crucial factor in heart failure and IHD, and modulating cardiac metabolism offers a new approach to treatment. However, current diagnostic modalities use ionizing radiation and have shown limited prognostic value.
Hyperpolarization through dynamic nuclear polarization (DNP) enables highly sensitive in vivo detection of metabolic processes. Hyperpolarized [1-13C]-pyruvate allows visualization of glycolysis-related metabolism, providing insights into the breakdown of glucose and its derivatives. By using this technique, the study aims to differentiate viable from non-viable myocardium in patients with IHD.
The objectives include implementing hyperpolarized [1-13C]-pyruvate cardiac MRI to image metabolic flux in the human heart and investigating the potential of this method to distinguish viable from non-viable myocardium in patients with IHD. The study endpoints involve assessing metabolic flux through the pyruvate dehydrogenase complex (PDC) and analyzing ratios of different metabolites, which can indicate the extent of pyruvate oxidation and lactate production.
A cross-sectional study design involving patients with CHF and ischemic heart disease will be used. Patients will undergo hyperpolarized [1-13C]-pyruvate MRI, PET imaging, late gadolinium enhancement (LGE) MRI, and cardiac magnetic resonance imaging (CMR). The study will compare [1-13C]-pyruvate MRI findings with PET results, allowing for a correlation between metabolic data and traditional imaging techniques. This innovative approach could provide valuable insights into the metabolic changes associated with ischemic heart disease
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic heart disease | – | Diagnostic Test: 13C-enriched pyruvate |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic heart disease treated at Aarhus University Hospital
Key inclusion criteria (10 listed)
- Chronic heart failure
- >18 years of age
- Left ventricular Ejection Fraction (LVEF) of 10 - 60 %
- Adequate hematologic and organ function.
- Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study.
Key exclusion criteria (6 listed)
- Not able or willing to receive heart failure therapy
- Patients not willing to participate
- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia
- Estimated Glomerular Filtration Rate (eGFR) <30 mL/min
- Insulin dependent Diabetes Mellitus
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 |
|---|---|---|
| 13C-enriched pyruvateBefore starting the hyperpolarization injection procedure, the patient will be scanned using the standard MR imaging defined in the clinical protocol and 13C prescriptions and a pre-scan will be completed. The clinical investigator will mount the administration syringe in the MR compatible power-injector with pre-adjusted injection volume calculated according to body weight (0.43 ml /kg bw). This setting is checked by the scanning operator and clinical investigator. The injection valve is set for agent delivery, and agent injected at a rate of 5 ml/s. The timings are monitored using a stopwatch on the SPINLAB. Following injection of hyperpolarized [1-13C]-Pyruvate , 20 ml of sterile saline in a separate syringe, already attached to the patient line, will be used to flush the IV line at the same injection rate (5 ml/s). | Diagnostic test | Ischemic heart disease |
Primary outcome
Quantitative numerical data given as metabolite ratios
Time frame: 45 minutes
[13C]-bicarbonate/[1-13C]-pyruvate ratio, b) [1-13C]-lactate / [1-13C]-pyruvate ratio and [1-13C]-lactate / [1-13C]-bicarbonate ratio. The latter gives ratio indices of PDC-mediated pyruvate oxidation and lactate production via lactate dehydrogenase.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Background: PubMed 17360992Neubauer S. The failing heart--an engine out of fuel. N Engl J Med. 2007 Mar 15;356(11):1140-51. doi: 10.1056/NEJMra063052. No abstract available.
- Background: PubMed 24103786Rider OJ, Tyler DJ. Clinical implications of cardiac hyperpolarized magnetic resonance imaging. J Cardiovasc Magn Reson. 2013 Oct 8;15(1):93. doi: 10.1186/1532-429X-15-93.
- Background: PubMed 12930897Ardenkjaer-Larsen JH, Fridlund B, Gram A, Hansson G, Hansson L, Lerche MH, Servin R, Thaning M, Golman K. Increase in signal-to-noise ratio of > 10,000 times in liquid-state NMR. Proc Natl Acad Sci U S A. 2003 Sep 2;100(18):10158-63. doi: 10.1073/pnas.1733835100. Epub 2003 Aug 20.
- Background: PubMed 18429038Golman K, Petersson JS, Magnusson P, Johansson E, Akeson P, Chai CM, Hansson G, Mansson S. Cardiac metabolism measured noninvasively by hyperpolarized 13C MRI. Magn Reson Med. 2008 May;59(5):1005-13. doi: 10.1002/mrm.21460.
- Background: PubMed 23258802Schroeder MA, Lau AZ, Chen AP, Gu Y, Nagendran J, Barry J, Hu X, Dyck JR, Tyler DJ, Clarke K, Connelly KA, Wright GA, Cunningham CH. Hyperpolarized (13)C magnetic resonance reveals early- and late-onset changes to in vivo pyruvate metabolism in the failing heart. Eur J Heart Fail. 2013 Feb;15(2):130-40. doi: 10.1093/eurjhf/hfs192. Epub 2012 Dec 19.
- Background: PubMed 27635086Cunningham CH, Lau JY, Chen AP, Geraghty BJ, Perks WJ, Roifman I, Wright GA, Connelly KA. Hyperpolarized 13C Metabolic MRI of the Human Heart: Initial Experience. Circ Res. 2016 Nov 11;119(11):1177-1182. doi: 10.1161/CIRCRESAHA.116.309769. Epub 2016 Sep 15.
- Background: PubMed 28186677Hansen ESS, Tougaard RS, Norlinger TS, Mikkelsen E, Nielsen PM, Bertelsen LB, Botker HE, Jorgensen HS, Laustsen C. Imaging porcine cardiac substrate selection modulations by glucose, insulin and potassium intervention: A hyperpolarized [1-13 C]pyruvate study. NMR Biomed. 2017 Jun;30(6). doi: 10.1002/nbm.3702. Epub 2017 Feb 10.
- Background: PubMed 33582059Apps A, Lau JYC, Miller JJJJ, Tyler A, Young LAJ, Lewis AJM, Barnes G, Trumper C, Neubauer S, Rider OJ, Tyler DJ. Proof-of-Principle Demonstration of Direct Metabolic Imaging Following Myocardial Infarction Using Hyperpolarized 13C CMR. JACC Cardiovasc Imaging. 2021 Jun;14(6):1285-1288. doi: 10.1016/j.jcmg.2020.12.023. Epub 2021 Feb 10. No abstract available.
- Individual participant dataSharing planned: No
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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.
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 Ischemic Heart Disease, run by Henrik Wiggers 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 10 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niels A. Jespersen, MD (+4522950990, nijesp@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative numerical data given as metabolite ratios (time frame: 45 minutes). 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 NCT06054516, which also lists 8 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 6 Mar 2026.