Prospective Investigation of Cirrhotic Cardiomyopathy in Humans (PITCH)
July 17, 2026 updated by: Manhal Izzy, Vanderbilt University Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Cirrhotic cardiomyopathy (CCM) is a recognized but understudied and not well understood complication of cirrhosis.
CCM is defined as subclinical (i.e., silent) heart dysfunction identified by echocardiography in patients with cirrhosis in the absence of other heart diseases such as significant coronary artery, valvular, or pericardial disease.
Initial small studies indicate that CCM is common and it warrants larger prospective study in humans to address unanswered questions highly relevant to clinical care.
These include 1) what are the associations between CCM and cirrhosis-related outcomes, adverse cardiac events, and survival 2) what clinical factors increase the risk for CCM, and 3) do bile acids levels, which are produced by the liver, in the blood associate with features of CCM.
Study Type
Observational
Enrollment (Estimated)
440
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Manhal Izzy, MD
- Phone Number: 615-875-6540
- Email: manhal.izzy@vumc.org
Study Contact Backup
- Name: Deepak Gupta, MD
- Email: d.gupta@vumc.org
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Vanderbilt University Medical Center
-
Principal Investigator:
- Manhal Izzy, MD
-
Contact:
- Manhal Izzy
- Phone Number: MD
- Email: manhal.izzy@vumc.org
-
Sub-Investigator:
- Deepak Gupta, MD
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Medical Center
-
Contact:
- Lisa VanWagner,, MD
- Phone Number: 214-648-3111
- Email: Lisa.Vanwagner@UTSouthwestern.edu
-
Sub-Investigator:
- Lisa Vanwagner, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Study population will be identified through clinic referrals and inpatient evaluations.
Description
Inclusion Criteria:
Decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following:
- portal hypertension-related bleeding,
- hepatic encephalopathy, and/or
- clinical ascites.
- Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C
- Age ≥ 18 years
- Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics
- Willing to adhere to study protocol
- Able to provide written informed consent
Exclusion Criteria:
- Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, > mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator
- End-stage heart, kidney, or lung disease
- Pulmonary Arterial Hypertension
- Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures)
- Advanced hepatocellular carcinoma (i.e., Barcelona Clinic Liver Cancer (BCLC) Stage C or D)
- Ongoing alcohol use, by patient reporting or by phosphatidyl ethanol testing
- Pregnancy
- Prior TIPS
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Decompensated cirrhosis
Patients with cirrhosis and current or prior occurrence of one or more of the following: • portal hypertension-related bleeding (a type of bleeding from the gut in patients with cirrhosis),• hepatic encephalopathy (i.e., alteration in mental status due to cirrhosis), and/or • clinical ascites (i.e., fluid build up in the abdomen). The cohort will then be analyzed based on the presence of cirrhotic cardiomyopathy. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-Cause Mortality
Time Frame: Up to 4 years
|
Death from any cause occurring during the follow-up period.
Mortality status will be ascertained through review of medical records.
|
Up to 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Manhal Izzy, MD, Vanderbilt University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Izzy M, VanWagner LB, Lin G, Altieri M, Findlay JY, Oh JK, Watt KD, Lee SS; Cirrhotic Cardiomyopathy Consortium. Redefining Cirrhotic Cardiomyopathy for the Modern Era. Hepatology. 2020 Jan;71(1):334-345. doi: 10.1002/hep.30875. Epub 2019 Oct 11.
- Kajal K, Premkumar M, Izzy M, Kulkarni AV, Duseja AK, Divyaveer S, Loganathan S, Sihag B, Gupta A, Bahl A, Rathi S, Taneja S, De A, Verma N, Sharma N, Kaur H, Zohmangaihi D, Kumar V, Bhujade H, Chaluvashetty SB, Kalra N. Cirrhotic cardiomyopathy influences clinical outcomes and enhances performance of conventional risk prediction models in acute-on-chronic liver failure with severe sepsis. Aliment Pharmacol Ther. 2023 Nov;58(9):903-919. doi: 10.1111/apt.17695. Epub 2023 Sep 9.
- Myers S, Gupta DK, Izzy M. The clinical relevance of the new criteria for cirrhotic cardiomyopathy and future directions. Liver Transpl. 2025 Apr 1;31(4):521-530. doi: 10.1097/LVT.0000000000000458. Epub 2024 Aug 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Study Registration Dates
First Submitted
June 15, 2026
First Submitted That Met QC Criteria
June 15, 2026
First Posted (Actual)
June 18, 2026
Study Record Updates
Last Update Posted (Actual)
July 21, 2026
Last Update Submitted That Met QC Criteria
July 17, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 250891
- R01HL181174 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.