Heart dysfunction in patients with liver cirrhosis

Not Applicable

Recruiting

• Conditions: cirrhosis; cirrhotic cardiomyopathy; hepatorenal syndrome; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12621000895886
• Lead Sponsor: Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-08
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Consecutive consenting cirrhotic patients with ascites and or past history of ascites on diuretics including
a)those requiring abdominal paracentesis,
b)hydrothorax requiring thoracentesis,
c)planned for TIPS.
2. Consecutive cirrhotic patients undergoing LT assessment with or without ascites.

Exclusion Criteria

1.ongoing sepsis on inotropes;
2.ongoing grade 2–4 hepatic encephalopathy;
3.known coronary artery disease;
4.other known cardiac diagnoses such as valvular heart disease, dilated, hypertrophic and restrictive cardiomyopathy
5. Uncontrolled systemic hypertension
5. Contraindications to dobutamine, including:
oPrevious sensitivity to dobutamine
oPrevious documented Ventricular Tachycardia or Ventricular Fibrillation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Define prevalence of CCM using Global Longitudinal strain (GLS) and Global myocardial work Index (GWI) at rest and under pharmacological stress if required<br><br><br>[12 months from the time of inclusion ];Composite outcome: Disease severity assessed by MELD score, aetiology of liver disease and the development of a number of specific complications of cirrhosis such refractory ascites and development of HRS, cardiac failure, and death. [12 months from the time of study recruitment];<br>Define critical threshold of GLS/GWI in patients with CCM using transthoracic echocardiography and dobutamine stress echocardiography[12 months from study recruitment]

Secondary Outcome Measures

Name	Time	Method
Composite outcome: Assess levels of troponin T and brain-natriuretic peptide using serum samples<br>[Within 12 months of recruitment and liver transplantation];Echocardiographic assessment post-transplant for CCM[Within 12 months of recruitment and liver transplantation]