Early Identification of Myocardial Impairment in PBC

NCT ID: NCT03545672

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2019-12-01

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.

Conditions

Primary Biliary Cholangitis; Cardiovascular Abnormalities

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PBC group

Patients have a definite PBC diagnosis.

CMR examination

Intervention Type: DIAGNOSTIC_TEST

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.

Control group

The healthy volunteers.

CMR examination

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

• Absence of known systemic diseases
• Normal examinations in CMR/Echo/ECG
• Age between 18-80 years old.
• 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)

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Jiang, MD

Role: STUDY_CHAIR

RenJi Hospital, School of Medicine, Shanghai Jiantong University

Xiong Ma, MD,PhD

Role: STUDY_CHAIR

RenJi Hospital, School of Medicine, Shanghai Jiantong University

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 34461299 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201709P

Identifier Type: -

Identifier Source: org_study_id