Clinical trial NCT03545672: Early Identification of Myocardial Impairment in PBC
Official title: EARLY Identification of MYOcardial Impairment in Primary Biliary Cholangitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Biliary Cholangitis
Cardiovascular Abnormalities
Keywords: Primary Biliary Cholangitis
Cardiac impairment
Cardiovascular Magnetic Resonance
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive subjects from three centers were prospectively enrolled into 2 cohorts between September 2017 and April 2019. The cohorts were divided as follows: the PBC patients group and the control group.

Brief 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.

Detailed description: Primary biliary cholangitis (PBC) is a progressive and uncommon inflammatory autoimmune cholesteric liver disease，which will contribute to cirrhosis. Symptoms and course of primary biliary cholangitis can be diverse, wherefore the targets of the current treatment are focused on the prevention of end-stage liver disease. 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. From our clinical practice, the cardiac structural abnormal can be found in certain patients with PBC detected by cardiovascular magnet resonance (CMR). CMR is the primary and emerging imaging modality for myocardial tissue characterization, and it is recommended as a gold standard for functional imaging and assessment. This three-center, multi-modality, prospective observational study plans to identify the type and the severity of cardiac changes in PBC.

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:

  1. History of elevated alkaline phosphatase (ALP) levels;
  2. Liver biopsy consistent with PBC;
  3. Positive antimitochondrial antibodies (AMA) or specific antinuclear antibodies;
* Providing written informed consent

Exclusion Criteria:

* History or presence of other concomitant liver disease including:

  1. cirrhosis or viral hepatitis;
  2. Inherited metabolic liver disease;
  3. Drug-induced liver injury;
  4. 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:

  1. Documented coronary artery disease;
  2. Ischemia/non-ischemia cardiomyopathy;
  3. Other systemic disease inducing heart change.
* Subjects with known liver disease including:

  1. Viral hepatitis;
  2. Inherited metabolic liver disease;
  3. Drug-induced liver injury;
  4. Other systemic disease inducing liver change.
* Subjects with standard metallic contraindications to CMR

Primary outcomes:
measure: The Incidence of Cardiac Events
timeFrame: 7 months after first CMR scanning
measure: Quantitative Assessment in Cardiac Injury
timeFrame: within 2 days of CMR scan
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiantong University
name: Meng Jiang, MD
role: STUDY_CHAIR
affiliation: RenJi Hospital, School of Medicine, Shanghai Jiantong University
name: Xiong Ma, MD,PhD
role: STUDY_CHAIR
References:
citation: Jiang P, Feng Z, Sheng L, Hu C, Ma X, Zhang S, Wu L, Xiao X, Wang Q, Guo C, Qiu D, Fang J, Xu J, Gershwin ME, Jiang M, Ma X, Pu J. Morphological, Functional, and Tissue Characterization of Silent Myocardial Involvement in Patients With Primary Biliary Cholangitis. Clin Gastroenterol Hepatol. 2022 May;20(5):1112-1121.e4. doi: 10.1016/j.cgh.2021.08.035. Epub 2021 Aug 28.