Clinical Trial: UTSW HP [13-C] Pyruvate Injection in HCM
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational
Official Title: Detection of Regional Myocardial Metabolic Changes in Patients With Hypertrophic Cardiomyopathy Using Hyperpolarized Carbon 13 Magnetic Resonance Spectroscopic Imaging (MR
Brief Summary: In this study the investigators propose to detect early mitochondrial metabolic changes in the heart in patients with a positive genotype and phenotype for Hypertrophic Cardiomyopathy (HCM) using a novel hyperpolarized [1-13C]pyruvate Magnetic Resonance Imaging (MRI) methodology.
Detailed Summary:
In this study the investigators propose to detect early mitochondrial metabolic changes in the heart in patients with a positive genotype and phenotype for HCM using a novel hyperpolarized [1-13C]pyruvate MRI methodology. Carbon-13 is a stable isotope (not radioactive) that makes up approximately 1.1% of all natural carbon. Carbon-13 has a non-zero spin quantum number that allows the investigation of carbon containing substances using magnetic resonance. However, compared with other analytical methods, carbon-13 magnetic resonance has been limited by an intrinsically low sensitivity [2}.
Recent experimental studies suggest that altered energy substrate metabolism may precede structural changes in myocardial hypertrophy. A better understanding of the myocardial metabolic changes in HCM is important, as the elucidation of such changes may precede the clinical development of myocardial fibrosis and malignant arrhythmias. Hyperpolarized [1-13C]pyruvate and its cellular metabolic flux can be assessed with a more than 10,000-fold higher sensitivity compared to traditional methods. The aim of this pilot study is to test the hypothesis that patients with HCM present focal alterations in myocardial hyperpolarized [1-13C]pyruvate flux.
To achieve this aim the investigators will assess myocardial metabolic changes in HCM subjects with a positive HCM genotype and phenotype (n=5) and in healthy control subjects (n=5) who are matched for age, sex, and Body Mass Index (BMI). Total target enrollment will be set at 15 subjects to allow for attrition and screen failures.
Cardiac function and structure will be evaluated with MRI (proton imaging) before and after contrast administration. Then myocardial metabolism will be assessed utilizing MRS (carbon spectroscopy) before and after intravenou
Sponsor: University of Texas Southwestern Medical Center
Current Primary Outcome: Hyperpolarized [1-13C]pyruvate flux [ Time Frame: Screening (Baseline) and 1 day of Study Visit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: January 10, 2017
Date Started: May 2017
Date Completion: April 2018
Last Updated: February 14, 2017
Last Verified: February 2017
