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N/A N=71

Myocardial Lipid and Creatine of Heart Failure on MRS

Myocardial Lipid

Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Myocaridal Lipid on MRS — 1.72; 1.18; 1.53; 0.93 ratios

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Proton (1H-) magnetic resonance (MR) spectroscopy (Other)
Age
Adult, Older Adult · 20+ yrs
Sex
All
Sponsor
Chang Gung Memorial Hospital
Primary completion
Dec 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Myocaridal Lipid on MRS
1.72; 1.18; 1.53; 0.93; 0.97; 1.39

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Data sourced from ClinicalTrials.gov (NCT02378402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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