Hypertension study: Hyperpolarized vs Gadolinium
Official title Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection
ClinicalTrials.gov ID: NCT02648009
What this study is testing
What is Hyperpolarized (13) Pyruvate Injection?
An investigational intravenous injection being studied for use with MRI to image heart metabolism in patients with hypertension or heart conditions.
Also referred to as Hyperpolarized Pyruvate (13) Injection.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a new MRI technique can safely show how the heart uses sugar. It looks at people with high blood pressure or heart muscle thickening.
- Who it's for
- You may be able to join if you have high blood pressure or a thickened heart muscle and are willing to have a special MRI scan.
- What's involved
- You will receive a small injection of a sugar that is labeled with a special carbon. Then you will lie in an MRI machine for about an hour while the machine takes pictures of your heart’s chemistry. No other treatments are given.
- Time commitment
- The study lasts about one hour for the MRI visit. No other visits are required.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.