Taking people in CanadaPhase 1

Imaging heart chemistry with an MRI-enhanced pyruvate injection in adults

Tests an MRI-enhanced pyruvate injection to image heart chemistry in adults with heart disease.

Key facts

Who runs it: Sunnybrook Health Sciences Centre
Where: Toronto, CanadaSee the 2 sites
Trial code: NCT02648009
Registry title: Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection
Status: Recruiting
Phase: Phase 1
People taking part: 112 people, planned
Started: Apr 2016
Expected to end: Apr 2027
Type of study: Interventional, 2 groups
Treatments tested: Hyperpolarized (13) Pyruvate Injection
Gadolinium
Record updated: 29 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in two groups: healthy volunteers aged 19 to 50, and people aged 30 to 75 with heart thickening, hypertrophic cardiomyopathy, stable heart failure or type 2 diabetes. It tests heart imaging with hyperpolarized (13C) pyruvate.

Age: 19 to 50 years in Arm 1; 30 to 75 years in Arm 2.
Sex: All sexes can join.
Disease stage: Arm 2 groups: left-ventricular hypertrophy; diagnosed hypertrophic cardiomyopathy; stable outpatients with NYHA class 1-3 heart failure and raised LV mass; or stable type 2 diabetes with HbA1c between 6.5-9% (48–75 mmol/mol) on oral hypoglycemic agents.
Earlier treatment: People with type 2 diabetes must be taking oral hypoglycemic agents. People who got another investigational medicine within 1 month before inclusion cannot join.
Biomarker or test result: HbA1c between 6.5-9% (48–75 mmol/mol) (type 2 diabetes groups only).

Main reasons for not taking part

Cannot have an MRI or MRI contrast agent
Medically diagnosed claustrophobia
Life expectancy under 1 year
BMI under 18.5 or over 32
Group 1: medically diagnosed heart disease

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

Written consent
Age: 19 to 50 in Arm 1, 30 to 75 in Arm 2
Group 2A and 2E participants have left-ventricular hypertrophy
Group 2B and 2F participants have diagnosed hypertrophic cardiomyopathy
Group 2C and 2G participants are stable outpatients with NYHA class 1-3 heart failure with evidence of elevated LV mass (LVH), irrespective of LVEF
Group 2D and 2H participants are stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents

Who cannot take part

Have received, or are scheduled to receive, another investigational medicinal product from 1 month prior to 1 month after inclusion in this study
Any condition leading to a life expectancy <1 year
Group 1: medically diagnosed heart disease
Hemoglobin ≤ 9.0 gm/dL (only Group 2 participants)
Contraindications to MRI or MRI contrast agents
Glomerular filtration rate (based on MDRD Equation) < 30 ml/min/1.73m2 (only Group 2 participants)
Medically diagnosed claustrophobia
BMI of less than 18.5 or greater than 32

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 19 and 75 years old?

Where in Canada

St. Michael's HospitalToronto, CanadaContact: Kim Connelly, MBBS PhD FRCPNot yet recruiting
Sunnybrook Health Sciences CentreToronto, CanadaContact: Norberto GarciaTaking people

About the trial

What the trial wants to find out

The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the health care system's most expensive diagnoses. Despite major advances in medicine, the mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI) is used for non-invasive imaging of the cardiovascular system to enable the structure and anatomy of the organ to be visualized. However, current MRI methods have limitations when assessing and aiding in the management of CHF. A new imaging method has recently been developed that is showing great promise as a tool in the management of patients with CHF. Rapid imaging of biochemical reactions within myocytes using MRI has recently become possible through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method. DNP-dissolution results in an intravenous contrast agent that is "hyperpolarized", producing a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13 labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods.

The 2 groups in the trial

Healthy VolunteersOther group
Arm 1 * Group 1A: control male volunteers between 19 and 50 years of age. * Group 1B: control female volunteers between 19 and 50 years of age. * Group 1C: control male or female volunteers between 19 and 50 years of age, with the MRI scan performed twice * Group 1D: control male volunteers between 19 and 50 years of age. * Group 1E: control female volunteers between 19 and 50 years of age. * Group 1F: control male or female volunteers between 19 and 50 years of age, with the MRI scan performed twice
Treatment: Hyperpolarized (13) Pyruvate Injection
Hypertension Hypertrophy VolunteersOther group
Arm 2 * Group 2A: patients aged 30 to 75 with hypertension and hypertrophy * Group 2B: patients aged 30 to 75 with non-obstructive hypertrophic cardiomyopathy (HCM). * Group 2C: stable outpatients with NYHA class 1-3 heart failure who have evidence of elevated LV mass (LVH), irrespective of LVEF. * Group 2D: stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents. * Group 2E: patients aged 30 to 75 with hypertrophy * Group 2F: patients aged 30 to 75 with hypertrophic cardiomyopathy (HCM). * Group 2G: stable outpatients with NYHA class 1-3 heart failure who have evidence of elevated LV mass (LVH), irrespective of LVEF. * Group 2H: stable patients with type 2 DM who have a HcA1c between 6.5-9% on oral hypoglycemic agents.
Treatment: Hyperpolarized (13) Pyruvate Injection and Gadolinium