UTSW HP [13-C] Pyruvate Injection in HCM

NCT03057002 | Completed FDA Drug

• 1 other identifier: STU 102016-046
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to identify the earliest changes in energy substrate metabolism in patients with cardiomyopathies (CMP). To achieve this objective, we plan first to test the hypothesis that patients with CMP present focal alterations in myocardial hyperpolarized \[1-13C\]pyruvate flux.

Conditions

Cardiomyopathy, Hypertrophic; Dilated Cardiomyopathy; Duchenne Muscular Dystrophy; Cardiac Sarcoidosis; Becker Muscular Dystrophy; Heart Failure With Preserved Ejection Fraction; Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Hyperpolarized [1-13C]pyruvate flux

  Measurement of change in myocardial hyperpolarized \[1-13C\]pyruvate flux during Magnetic Resonance Spectroscopic Imaging.

  Screening (Baseline) and 1 day of Study Visit

Study Arms (2)

Cardiomyopathy

Patients with Cardiomyopathy will be observed for myocardial hyperpolarized 13C-pyruvate flux during magnetic resonance spectroscopic imaging.

Diagnostic Test: Hyperpolarized 13C-Pyruvate

Control

Healthy control subjects will be observed for myocardial hyperpolarized 13C-pyruvate flux during magnetic resonance spectroscopic imaging.

Diagnostic Test: Hyperpolarized 13C-Pyruvate

Interventions

Hyperpolarized 13C-Pyruvate DIAGNOSTIC_TEST

All subjects will be observed for myocardial hyperpolarized \[1-13C\]pyruvate flux during magnetic resonance spectroscopic imaging.

Also known as: HP [1-13C]pyruvate

Cardiomyopathy; Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

5 Cardiomyopathy (CMP) Patients and 5 Healthy Controls

You may qualify if:

• Subjects who are 18.
• Subjects who have the ability to understand and the willingness to sign a written informed consent.
• While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Subjects who are 18.
• Subjects who have the ability to understand and the willingness to sign a written informed consent.
• While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

You may not qualify if:

• Subjects who are receiving any other investigational agents.
• Intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled chronic diseases such as hypertension, lung disease, liver disease, kidney disease, diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects who are taking thyroid hormone replacements, have a history of alcohol abuse or illicit drug use.
• Subjects who have contraindication to contrast enhanced MRI examination.
• Contraindications to MRI examinations include:
• Medically unstable
• Acute Heart failure
• Severe LVOT obstruction
• Unstable angina
• Child bearing
• Lactating
• Any contraindication per MRI Screening Form including
• Implants contraindicated at 3Tesla, pacemakers
• Implantable Cardioverter Defibrillator (ICD)
• Claustrophobia

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center - Advanced Imaging Research Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated; Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked

Study Officials

• Vlad G Zaha, MD, PhD

  Advanced Imaging Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: February 17, 2017
• Study Start: May 1, 2018
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)