Early Identification of Myocardial Impairment in PBC

Primary Biliary Cholangitis Clinical Trial

— EARLY-MYO-PBC  

Official title:

EARLY Identification of MYOcardial Impairment in Primary Biliary Cholangitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545672
• Other study ID #: 201709P
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: April 3, 2019

Study information

• Verified date: May 2019
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 characterisation, and it is recommended as a gold standard for functional imaging and assessment. This single-center, prospective observational study plans to identify the type and the severity of cardiac changes in PBC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 3, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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. Viral hepatitis;

2. Inherited metabolic liver disease;

3. Drug-induced liver injury;

4. Other systemic disease inducing liver change.

• Subjects with known ischemic/non-ischemic cardiomyopathy.

• 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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• Cholangitis
• Liver Cirrhosis, Biliary
• Primary Biliary Cholangitis

Intervention

Diagnostic Test:
• CMR examination
After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of cardiac involvement	Assessments base on the cardiac structure, function and tissue characterization	through study completion, an average of 14 months
Primary	Composite endpoint of quantitative assessment in cardiac injury	Compose of extracellular volume(%), T1 value(ms) and T2 value(ms).	within 2 days of CMR scan
Secondary	Composite endpoint of liver condition	Compose of the alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ,alkaline phosphatase (AKP) and bilirubin indicating the liver condition and prognosis.	within 2 days of CMR scan
Secondary	Composite endpoint of cardiac function	Compose of CRP (hs-CRP), troponin I (TnI) and hematocrit indicating the cardiac function	within 2 days of CMR scan