Observational Study of Cirrhotic Cardiomyopathy

This study is looking into cirrhotic cardiomyopathy (CCM), a heart problem that can affect people with cirrhosis (severe liver scarring). While CCM is known to be a complication of cirrhosis, it's not well understood, even though it might affect one in three people with advanced cirrhosis and increase the risk of death and other health issues. This study will observe 440 adults with cirrhosis to better understand CCM. Researchers want to see how CCM is linked to outcomes of cirrhosis, heart problems, and survival. They also want to find out what factors might increase your risk for CCM and if bile acid levels in your blood are related to CCM. You might be able to join if you are 18 or older and have decompensated cirrhosis (cirrhosis with complications like bleeding, confusion, or fluid buildup) and a MELD 3.0 score of 15 or higher, or Child Pugh Class B-C.

Study design
This is an observational study involving 440 participants. It is designed to look at how cirrhotic cardiomyopathy affects people with cirrhosis.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 4 years to track all-cause mortality (death from any cause).

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NCT07658222

Prospective Investigation of Cirrhotic Cardiomyopathy in Humans

Recruiting
Not specifiedAges 18+Observational
Vanderbilt University Medical Center
~440 participants
Updated 2026-07-21 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
All-Cause Mortality
Measured over Up to 4 years
Cirrhotic Cardiomyopathy
2 sites across 2 states
Tennessee1
Texas1
  • Manhal Izzy, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Eligibility criteria

Inclusion

portal hypertension-related bleeding,
hepatic encephalopathy, and/or
clinical ascites. 2. Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C 3. Age ≥ 18 years 4. Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics 5. Willing to adhere to study protocol 6. Able to provide written informed consent
  • All-Cause MortalityUp to 4 years

    Death from any cause occurring during the follow-up period. Mortality status will be ascertained through review of medical records.