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Diagnostic Agent

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

Study Summary

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

Eligible Conditions

Enlargement
High Blood Pressure

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Heart

Secondary outcome measures

Imaging of participant's heart with Gadolinium

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

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,325 Total Patients Enrolled

Charles Cunningham, PhDPrincipal InvestigatorSunnybrook Research Institute

5 Previous Clinical Trials

159 Total Patients Enrolled

Media Library

Hyperpolarized (13C) Pyruvate Injection (Diagnostic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02648009 — Phase 1

Enlargement Research Study Groups: Healthy Volunteers, Hypertension Hypertrophy Volunteers

Enlargement Clinical Trial 2023: Hyperpolarized (13C) Pyruvate Injection Highlights & Side Effects. Trial Name: NCT02648009 — Phase 1

Hyperpolarized (13C) Pyruvate Injection (Diagnostic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02648009 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being considered for this clinical investigation?

"The eligibility criteria for this clinical trial clearly state that 19 is the minimum age requirement and 75 years old is the maximum allowable."

Answered by AI

Is it still feasible to join this research endeavor?

"Information furnished on clinicaltrials.gov affirms that this experiment is actively enrolling participants, with the initial listing made public on April 1st 2016 and latest edit dating back to March 27th 2023."

Answered by AI

What criteria is necessary to take part in this experiment?

"Candidates between 19 and 75 years of age with enlarged organs may be eligible for this study, which is currently recruiting 112 participants."

Answered by AI

Has this treatment been explored in past medical research studies?

"As of now, 11 trials concerning this intervention are live with 0 in the third phase. There are 13 separate medical sites providing clinical trials for it; a majority being located in Portland, Oregon."

Answered by AI

Has this therapy been sanctioned by the FDA?

"As this is an early Phase 1 trial, there are only preliminary indications of the treatment's safety and efficacy. Therefore, our team has conservatively assigned a rating of 1 to its security profile."

Answered by AI

What is the current number of participants signed up for this experiment?

"Affirmative, the data available on clinicaltrials.gov confirms that this medical study is actively recruiting patients at present. It was initially posted in April 2016 and last modified in March 2021, with a total patient requirement of 112 across two sites."

Answered by AI

Recent research and studies

Circulation ResearchJournal

Hyperpolarized <sup>13</sup> C Metabolic MRI of the Human Heart

Cunningham, Charles H., Justin Y.C. Lau, Albert P. Chen, Benjamin J. Geraghty, William J. Perks, Idan Roifman, Graham A. Wright, and Kim A. Connelly. 2016. “Hyperpolarized 13 C Metabolic MRI of the Human Heart”. Circulation Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circresaha.116.309769.

clinicaltrials.govStudy

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

2016. "Metabolic Imaging of the Heart Using Hyperpolarized (13C) Pyruvate Injection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02648009.

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