Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients

RECRUITING

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Despite medical and surgical advances, long-term survival in liver transplant (LT) recipients is compromised by an increased risk of cardiovascular disease (CVD) after transplant, the mechanisms of which are still not fully understood. TMAO is an attractive therapeutic target to improve vascular health and diastolic function toward preventing CVD in LT patients. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.

Conditions:

🦠 Liver Transplant

🗓️ Study Start (Actual) 18 January 2024

🗓️ Primary Completion (Estimated) 15 September 2025

✅ Study Completion (Estimated) 15 September 2025

👥 Enrollment (Estimated) 30

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Richmond, Virginia, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Aged \> 18 years
* Speak and understand English
* Have received and LT

Exclusion Criteria:

* Acute cellular or chronic rejection within 3 months
* Post-LT liver or non-liver related malignancy
* Active viral hepatitis (B or C) or autoimmune hepatitis
* Untreated biliary strictures or vascular complications (e.g. hepatic artery thrombosis)
* Poorly controlled diabetes (HbA1c \>8.5%)
* Relapse of alcohol use after LT
* Follow a vegetarian or vegan diet
* Current pregnancy
* Unable to provide informed consent

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

First Submitted 12 September 2023
First Submitted that Met QC Criteria 12 September 2023
First Posted 21 September 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 4 March 2024
Last Update Posted 6 March 2024
Last Verified March 2024