Highly detailed measurements of metabolism in the heart muscle in patients with chronic heart failure.

Clinical and pathophysiological aspects of visualization of metabolic flux in the failing human heart using hyperpolarized [1-13C]-pyruvate cardiac magnetic resonance

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003533-15-DK

Enrollment

Registered

2018-11-01

Start date

2018-12-04

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure MedDRA version: 20.0 Level: LLT Classification code 10007540 Term: Cardiac disorder NOS System Organ Class: 100000004849

Interventions

Product Name: [1-13C]Pyruvate Product Code: [1-13C]Pyruvate Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Dilated Cardiomyopathy > 18 years of age. Diagnosis of Dilated Cardiomyopathy (DCM) Left ventricular Ejection Fraction (LVEF) of 10 – 45 % Adequate hematologic and organ function, i.e. ANC at least 1.500/uL Platelet count >100/uL Se bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 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 Receiving more than 50% of taget dose of ACE-inhibitor and betablockers before inclusion Previous heart surgery including PCI Estimated Glomerular Filtration Rate (eGFR) <30 mL/min Diabetes Mellitus Intolerance to Pyruvate

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To implement hyperpolarized [13C]-pyruvate cardiac MR to successfully image metabolic flux in the human heart. 2) To investigate whether specific "metabolic fingerprints of the failing heart" differentiate patients with different severities of heart failure. 3) To determine metabolic changes in the failing human heart before and after optimization of medical heart failure treatment. 4) To investigate if hyperpolarized [13C]-pyruvate cardiac MR metabolic fingerprints can differentiate responders from non-responders to medical treatment.;Secondary Objective: To establish whether the sensitivity of MR-hyperpolarized [1-13C]Pyruvate based MR-spectroscopy is high enough for future studies of therapy effects.;Primary end point(s): The scanning program is terminated after 20 patients have been examined before and after uptitration in heart failure medication using the MR-hyperpolarization scanning technique;Timepoint(s) of evaluation of this end point: The final endpoint is reached when the planned examinations are completed. Additionally, if two or more at least grade three AEs related to C13-Pyruvate occur at the established dose level of 0.43 mg/kg among the first 5 patients, the dose of 13C-Pyruvate will be reduced. If two or more at least grade three AEs related to the drug occur at the reduced dose level in the subsequent five patients, the experiment will be disrupted. If grade four AEs or any SAEs related to the drug occur, each event will be reviewed by the protocol group with respect to safety and consideration of study disruption	—

Measure

Time frame

Main Objective: 1) To implement hyperpolarized [13C]-pyruvate cardiac MR to successfully image metabolic flux in the human heart. 2) To investigate whether specific "metabolic fingerprints of the failing heart" differentiate patients with different severities of heart failure. 3) To determine metabolic changes in the failing human heart before and after optimization of medical heart failure treatment. 4) To investigate if hyperpolarized [13C]-pyruvate cardiac MR metabolic fingerprints can differentiate responders from non-responders to medical treatment.;Secondary Objective: To establish whether the sensitivity of MR-hyperpolarized [1-13C]Pyruvate based MR-spectroscopy is high enough for future studies of therapy effects.;Primary end point(s): The scanning program is terminated after 20 patients have been examined before and after uptitration in heart failure medication using the MR-hyperpolarization scanning technique;Timepoint(s) of evaluation of this end point: The final endpoint is reached when the planned examinations are completed. Additionally, if two or more at least grade three AEs related to C13-Pyruvate occur at the established dose level of 0.43 mg/kg among the first 5 patients, the dose of 13C-Pyruvate will be reduced. If two or more at least grade three AEs related to the drug occur at the reduced dose level in the subsequent five patients, the experiment will be disrupted. If grade four AEs or any SAEs related to the drug occur, each event will be reviewed by the protocol group with respect to safety and consideration of study disruption

—

Secondary

Measure	Time frame
Secondary end point(s): intermediate endpoints relate to sensitivity of the hyperpolarised scanning technology for demonstrating therapy effects;Timepoint(s) of evaluation of this end point: After the first five patients are hypperpolarization data examined for expected sensitivity of the applied scanning technology.	—

Countries

Denmark

Contacts

Public ContactDepartment of Cardiology

Department of Cardiology Aarhus University

00452275 3202

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026