Recruiting
Phase 1

DNP with 13C-Pyruvate

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT02648009

Conditions

Hypertension

Hypertrophy

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

Interventions

Hyperpolarized (13) Pyruvate Injection

Gadolinium

Study Details

Brief summary:

The prevalence of congestive heart failure (CHF) in Canada is high, representing one of the health care system's most expensive diagnoses. Despite major advances in medicine, the mortality and morbidity from CHF remains great. Currently, magnetic resonance imaging (MRI) is used for non-invasive imaging of the cardiovascular system to enable the structure and anatomy of the organ to be visualized. However, current MRI methods have limitations when assessing and aiding in the management of CHF. A new imaging method has recently been developed that is showing great promise as a tool in the management of patients with CHF. Rapid imaging of biochemical reactions within myocytes using MRI has recently become possible through the use of the Dynamic Nuclear Polarization (DNP) and dissolution method. DNP-dissolution results in an intravenous contrast agent that is "hyperpolarized", producing a magnetic signal that is enhanced by up to 100,000 fold. The particular agent is carbon-13 labelled pyruvate. In this study, we demonstrate the first 13C-metabolic images of the human heart, along with the required hardware and data acquisition methods.

Conditions

Hypertension

Hypertrophy

Study ID

NCT02648009

Start date

Apr, 2016

Status verified date

Jan, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Healthy Volunteers

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

other: Hypertension Hypertrophy Volunteers

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.

Interventions

Hyperpolarized (13) Pyruvate Injection

MRI with Hyperpolarized Pyruvate (13) Injection

Gadolinium

MRI with Gadolinium

Primary outcome measure

  • Ability of the MRI machine to produce an image of the participant's heart following an injection of Hyperpolarized Pyruvate (13C) as assessed by the physician [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Norberto Garcia

4164806100norberto.garcia@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Norberto Garcia

4164806100norberto.garcia@sunnybrook.ca

Principal Investigator:

Charles Cunningham, PhD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-01-29.