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Prospective Investigation of Cirrhotic Cardiomyopathy in Humans (PITCH)

17. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Cirrotisk kardiomyopati

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

440

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Manhal Izzy, MD
Telefonnummer: 615-875-6540
E-post: manhal.izzy@vumc.org

Studer Kontakt Backup

Navn: Deepak Gupta, MD
E-post: d.gupta@vumc.org

Studiesteder

Forente stater
- Tennessee
  - Nashville, Tennessee, Forente stater, 37203
    - Rekruttering
    - Vanderbilt University Medical Center
    - Hovedetterforsker:
      
      Manhal Izzy, MD
    - Ta kontakt med:
      
      Manhal Izzy
      
      Telefonnummer: MD
      
      E-post: manhal.izzy@vumc.org
    - Underetterforsker:
      
      Deepak Gupta, MD
- Texas
  - Dallas, Texas, Forente stater, 75390
    - Rekruttering
    - UT Southwestern Medical Center
    - Ta kontakt med:
      
      Lisa VanWagner,, MD
      
      Telefonnummer: 214-648-3111
      
      E-post: Lisa.Vanwagner@UTSouthwestern.edu
    - Underetterforsker:
      
      Lisa Vanwagner, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Study population will be identified through clinic referrals and inpatient evaluations.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
All-Cause Mortality Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vanderbilt University Medical Center

Samarbeidspartnere

National Heart, Lung, and Blood Institute (NHLBI)

National Institutes of Health (NIH)

Etterforskere

Hovedetterforsker: Manhal Izzy, MD, Vanderbilt University Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. januar 2026

Primær fullføring (Antatt)

30. juni 2030

Studiet fullført (Antatt)

30. juni 2030

Datoer for studieregistrering

Først innsendt

15. juni 2026

Først innsendt som oppfylte QC-kriteriene