Clinical Trial

Prospective Investigation of Cirrhotic Cardiomyopathy in Humans

Study acronym: PITCH
Recruiting
View on ClinicalTrials.gov →
Summary
Cirrhotic Cardiomyopathy (CCM) is a recognized complication of cirrhosis, but understudied despite recent retrospective data suggesting it may be common, affecting one in three patients with decompensated cirrhosis, and associated with significantly increased risk of death and adverse hepatic and cardiac events. Moreover, evidence from preclinical models and children suggest elevated bile acids in the blood may contribute to CCM, but data from adults with cirrhosis are scarce. Therefore, this study will be the first contemporary prospective multicenter investigation of CCM in adults with cirrhosis in the United States. The study will characterize risk factors for CCM, determine its impact on clinical outcomes, and investigate the contribution of circulating bile acids to disease development.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-22
Trial Details
NCT Number NCT07658222
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Conditions Cirrhotic Cardiomyopathy
Enrollment 440 participants
Start Date 2026-01-20
Primary Completion 2030-06-30 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-21