Status:
UNKNOWN
Hyperpolarized MRSI in Ischemic Heart Disease: A Metabolic Investigation of the Heart Muscle
Lead Sponsor:
Henrik Wiggers
Conditions:
Ischemic Heart Disease
Eligibility:
All Genders
18-90 years
Brief 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). ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 13 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06054516
Start Date
October 13 2023
End Date
January 31 2025
Last Update
November 2 2023
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Central Jutland, Denmark, 8200