Clinical trial NCT02378402: Myocardial Lipid and Creatine of Heart Failure on MRS
Official title: Exploring Myocardial Lipid and Creatine as Imaging Biomarkers for Patients of Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Lipid
Keywords: Creatine
heart failure
lipid
MRS
myocardium
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 71
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute HF episode with hospitalization treatment within 12 months were enrolled.

Brief summary: The objective of this 3-year project is to develop myocardial MRS, in particular lipid (triglyceride) and creatine resonances, as imaging biomarkers for patients with heart failure (HF). Investigators will elucidate how and, to what extent, lipid and creatine levels of the heart contribute to heart failure. The first year is a cross-sectional study. Investigators aim to compare the MRS of normal subjects and that of stable HF patients in recovery with normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each group. In the 2nd and 3rd years, investigators plan a prospective longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac MRS at three time points, i.e., disease onset, 6 months and one year after treatment, and will be followed up until the end of this project (1.5\~3-year follow up). In total 120 MR scans will be performed in the 2nd and 3rd years. The resonances from cardiac MRS, including creatine and lipids, will be correlated with the disease course, patient biochemistry data and clinical outcome. Investigators expect to make MRS to become an integral part of a clinical cardiac MR protocol.

Detailed description: Heart failure (HF) is a major societal burden due to its high prevalence, poor prognosis and high cost. A potential therapeutic target is to supply the energy-starved heart. Lipid content of the heart is highly dynamic and myocardial lipid overload has been implicated in the pathophysiology of cardiac disease. The measurement of total creatine, a crucial actor in the creatine kinase system, gives an insight into the energy storage and buffering capacity in the heart. Magnetic Resonance Spectroscopy (MRS) is an imaging technique that allows non-invasive biochemical analysis in the clinical setting using routine MR scanner. It has the combined advantages of inherently providing molecular information, being free of ionizing radiation, and not requiring administration of external tracers. The objective of this 3-year project is to develop myocardial MRS, in particular lipid (triglyceride) and creatine resonances, as imaging biomarkers for patients with heart failure (HF). Investigators will elucidate how and, to what extent, lipid and creatine levels of the heart contribute to heart failure. The first year is a cross-sectional study. Investigators aim to compare the MRS of normal subjects and that of stable HF patients in recovery with normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each group. In the 2nd and 3rd years, investigators plan a prospective longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac MRS at three time points, i.e., disease onset, 6 months and one year after treatment, and will be followed up until the end of this project (1.5\~3-year follow up). In total 120 MR scans will be performed in the 2nd and 3rd years. The resonances from cardiac MRS, including creatine and lipids, will be correlated with the disease course, patient biochemistry data and clinical outcome. Investigators expect to make MRS to become an integral part of a clinical cardiac MR protocol. The advance in knowledge is to prove the association between heart failure and myocardial impairment in lipids and/or creatine. The knowledge gained from MRS could potentially translate as a non-invasive biomarker for heart failure patients. This biomarker can help to early detect treatable causes of HF, and to monitor and evaluate treatment response in a non-invasive fashion. The inherited non-invasiveness and non-radiation nature makes MR an ideal technique for clinical application and biotechnology development.

Eligibility criteria: Inclusion Criteria:

1. heart failure patients diagnosed in the Keelung Chang Gung Memorial Hospital
2. without previous history of coronary artery disease
3. patients must be ≥ 20 and ≤ 80 years of age
4. patients must be willing to undergo standard treatment and follow up in the Heart Failure Center
5. patients must be able to give informed consent.

Exclusion Criteria:

1. patients who are judged to be noncompliant to treatment or not accessible for follow up
2. patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants, or unable to cooperate for MRI study due to mental status
3. Severe renal function impairment (glomerular filtration rate less than 30 mL/min/1.73m2)
4. pregnant or breast-feeding status
5. history of open-heart surgery.

Primary outcomes:
measure: Myocaridal Lipid on MRS
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Guishan
country: Taiwan
facility: Department of Radiology, Chang Gung Memorial Hospital
state: Taoyuan
Study officials:
References:
citation: Liao PA, Lin G, Tsai SY, Wang CH, Juan YH, Lin YC, Wu MT, Yang LY, Liu MH, Chang TC, Lin YC, Huang YC, Huang PC, Wang JJ, Ng SH, Ng KK. Myocardial triglyceride content at 3 T cardiovascular magnetic resonance and left ventricular systolic function: a cross-sectional study in patients hospitalized with acute heart failure. J Cardiovasc Magn Reson. 2016 Feb 5;18:9. doi: 10.1186/s12968-016-0228-3.