UTSW HP [13-C] Pyruvate Injection in HCM

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03057002
• Date of registration: 10/01/2017
• Prospective Registration: Yes
• Primary sponsor: University of Texas Southwestern Medical Center
• Public title: UTSW HP [13-C] Pyruvate Injection in HCM HPHCM
• Scientific title: Detection of Myocardial Metabolic Changes in Patients With Cardiomyopathy Using Hyperpolarized Carbon 13 Magnetic Resonance Spectroscopic Imaging
• Date of first enrolment: May 1, 2018
• Target sample size: 128
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03057002
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Syed Ahsan, MPH

• Name: Vlad G Zaha, MD, PhD
• Affiliation: Advanced Imaging Research Center

• Name: Syed Ahsan

Key inclusion & exclusion criteria

Inclusion Criteria for Control Subjects:

- 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.

Inclusion Criteria for participants with Cardiomyopathy:

- 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.

Exclusion criteria:

- 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

- Since each subject is receiving a gadolinium based contrast agent intravenously:

- eGFR = 30 mL/min/1.73m2

- Sickle cell disease

- Hemolytic anemia



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy

Heart Failure With Reduced Ejection Fraction

Cardiomyopathy, Hypertrophic

Heart Failure With Preserved Ejection Fraction

Becker Muscular Dystrophy

Cardiac Sarcoidosis

Dilated Cardiomyopathy

Intervention(s)

Diagnostic Test: Hyperpolarized 13C-Pyruvate

Primary Outcome(s)

Hyperpolarized [1-13C]pyruvate flux [Time Frame: Screening (Baseline) and 1 day of Study Visit]

Secondary ID(s)

STU 102016-046

Source(s) of Monetary Support

Please refer to primary and secondary sponsors