Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Jan 4, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new way to take pictures of the heart using a special substance called hyperpolarized carbon-13 pyruvate. This method aims to improve how doctors can see and understand heart conditions, particularly in patients with congestive heart failure, high blood pressure, and thickening of the heart muscle. Traditional MRI scans are helpful but have some limitations when it comes to assessing heart function. The new technique could provide better insights into the heart's metabolism, which may help in managing these conditions more effectively.

To participate in this trial, you need to be between 19 and 75 years old and give your written consent. There are specific groups based on your heart condition, such as those with left-ventricular hypertrophy or stable heart failure. You won’t be able to join if you have certain medical conditions that could prevent you from safely undergoing an MRI, or if you have other serious health issues. If you qualify, you can expect to receive the hyperpolarized substance through an IV and undergo MRI imaging to help researchers learn more about your heart’s function. This study is currently recruiting participants, and your involvement could contribute to important advancements in heart health care.

Gender

ALL

Eligibility 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