N/A
N=119
Early Identification of Myocardial Impairment in PBC
Primary Biliary Cholangitis · Cardiovascular Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT03545672 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: The Incidence of Cardiac Events — 0; 0; 0; 0 Participants — p=0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- CMR examination (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RenJi Hospital
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Cardiac Events |
0; 0; 0; 0; 0; 0 | 0.001 sig |
| PRIMARY Quantitative Assessment in Cardiac Injury |
30; 26 | <0.01 sig |
Summary
Primary biliary cholangitis (PBC) is a chronic inflammatory liver disease leading to cirrhosis. Researches reported patients with PBC may involve abnormalities on skeleton, thyroid and exocrine glands. However, whether this autoimmune disease would cause cardiac impairment is scarcely investigated. Cardiovascular Magnetic Resonance(CMR) is recently developed as a reliable modality to evaluate the cardiac tissue characteristics and functions. This study aims to investigate the cardiac status in PBC patients based on CMR.
Eligibility Criteria
Inclusion Criteria for PBC group:
- Age between 18-80 years old.
- Definite primary biliary cirrhosis diagnosis which is consistent with European Association for the Study of the Liver (EASL) [Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis (2017)]. The following three diagnostic factors, at least meet two:
- History of elevated alkaline phosphatase (ALP) levels;
- Liver biopsy consistent with PBC;
- Positive antimitochondrial antibodies (AMA) or specific antinuclear antibodies;
- Providing written informed consent
Exclusion Criteria
- History or presence of other concomitant liver disease including:
- cirrhosis or viral hepatitis;
- Inherited metabolic liver disease;
- Drug-induced liver injury;
- Other systemic disease inducing liver change.
- Subjects with life expectancy < 6 months.
- Subjects with known ischemic/non-ischemic cardiomyopathy or abnormal in cardiac-related examinations.
- Subjects with standard metallic contraindications to CMR (i.e., estimated glomerular filtration rate < 30 ml/min/1.73 m2, New York Heart Association functional capacity class IV)
Inclusion Criteria for Control group:
- Absence of known systemic diseases
- Normal examinations in CMR/Echo/ECG
- Age between 18-80 years old.
- Providing written informed consent
Exclusion Criteria
- Subjects with known heart disease including:
- Documented coronary artery disease;
- Ischemia/non-ischemia cardiomyopathy;
- Other systemic disease inducing heart change.
- Subjects with known liver disease including:
- Viral hepatitis;
- Inherited metabolic liver disease;
- Drug-induced liver injury;
- Other systemic disease inducing liver change.
- Subjects with standard metallic contraindications to CMR
Data sourced from ClinicalTrials.gov (NCT03545672). 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.