Pyruvate Imaging for High Blood Pressure

Phase 1

Recruiting

Led By Charles Cunningham, PhD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial demonstrates the potential for a new MRI imaging method to help manage patients with congestive heart failure.

Who is the study for?

This trial is for adults with heart enlargement or high blood pressure. Participants aged 19-50 and 30-75 are needed, depending on the group they fall into. They must have specific heart conditions like left-ventricular hypertrophy, diagnosed cardiomyopathy, stable heart failure with elevated LV mass, or type 2 diabetes with controlled HcA1c levels.

What is being tested?

The study tests a new MRI method using Hyperpolarized (13C) Pyruvate Injection to improve imaging of the cardiovascular system in patients with congestive heart failure. This could help doctors better manage CHF by visualizing biochemical reactions in heart cells more clearly.

What are the potential side effects?

Potential side effects may include those typically associated with MRI contrast agents such as Gadolinium: allergic reactions, headache, nausea, dizziness, and cold sensations at the injection site. The hyperpolarized agent's risks are still being evaluated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart

Secondary study objectives

Imaging of participant's heart with Gadolinium

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Hypertension Hypertrophy VolunteersExperimental Treatment2 Interventions

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.

Group II: Healthy VolunteersExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Gadolinium

2006

Completed Phase 4

~620

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