NCT02648009RecruitingPhase 1
Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 3 Dec 2015
- Start date
- 1 Apr 2016
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Diseases
- High blood pressure
- NCT number
- NCT02648009
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 112
- From 1 Apr 2016 to the primary completion date, 30 Apr 2027
- 2 sites 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.
Prior treatment
- Have received, or are scheduled to receive, another investigational medicinal product from 1 month prior to 1 month after inclusion in this study
Other illness
- Any condition leading to a life expectancy \<1 year
- Group 1: medically diagnosed heart disease
Lab values
- Hemoglobin ≤ 9.0 gm/dL (only Group 2 participants)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.