NCT06054516Recruiting
Hyperpolarized MRSI in Ischemic Heart Disease: A Metabolic Investigation of the Heart Muscle
Hyperpolarized MRSI in Ischemic Heart Disease: Metabolic Profiling of the Myocardium
Source: ClinicalTrials.gov · Last updated 6 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 20 Sept 2023
- Start date
- 13 Oct 2023
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Henrik Wiggers
- Diseases
- Coronary artery disease
- NCT number
- NCT06054516
What you commit to
- Study type: Observational
- Planned participants: 15
- From 13 Oct 2023 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Not able or willing to receive heart failure therapy
- Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia
- Insulin dependent Diabetes Mellitus
Lab values
- Estimated Glomerular Filtration Rate (eGFR) \<30 mL/min
Other
- Patients not willing to participate
- Intolerance to Pyruvate
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.