Imaging the heart's metabolism using a special carbon-13 compound
Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection
PHASE1 · Sunnybrook Health Sciences Centre · NCT02648009
This study is testing a new imaging method using a special carbon-13 compound to see how well the hearts of people with high blood pressure and thickened heart muscle are working.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre (other) |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT02648009 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel imaging technique using hyperpolarized carbon-13 pyruvate injection to assess heart metabolism in individuals with hypertension and hypertrophy. Participants will undergo MRI scans after receiving a glucose drink to optimize imaging results. The goal is to gain insights into heart failure treatments by visualizing biochemical reactions in the heart, potentially leading to earlier interventions and improved patient outcomes. The study will compare different labeling patterns of the pyruvate to gather comprehensive metabolic data.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 to 75 with hypertension, hypertrophic cardiomyopathy, or stable heart failure.
Not a fit: Patients with contraindications to MRI, severe anemia, or life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier treatment options for heart failure, reducing morbidity and mortality rates associated with the condition.
How similar studies have performed: While this imaging method is novel, similar approaches using advanced MRI techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * 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 Exclusion Criteria * Contraindications to MRI or MRI contrast agents * Hemoglobin ≤ 9.0 gm/dL (only Group 2 participants) * Glomerular filtration rate (based on MDRD Equation) \< 30 ml/min/1.73m2 (only Group 2 participants) * Any condition leading to a life expectancy \<1 year * Medically diagnosed claustrophobia * Have received, or are scheduled to receive, another investigational medicinal product from 1 month prior to 1 month after inclusion in this study * BMI of less than 18.5 or greater than 32 * Group 1: medically diagnosed heart disease
Where this trial is running
Toronto, Ontario and 1 other locations
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
- St. Michael's Hospital — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Charles Cunningham, PhD — Sunnybrook Research Institute
- Study coordinator: Norberto Garcia
- Email: norberto.garcia@sunnybrook.ca
- Phone: 4164806100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Hypertrophy