Skip to main content
OpenTrials
Completed

NCT Number: NCT06043531

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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. Following LT, patients have an increased incidence of atherosclerotic CVD. Notably, atherosclerotic CVD is an established risk factor for diastolic dysfunction and incident heart failure with preserved ejection fraction (HFpEF). There is a critical need to better understand the biological mechanisms of LT related vascular dysfunction and establish targeted interventions that will reduce the risk of CVD in this patient population. In the general population, there is strong epidemiological evidence linking high TMAO levels with atherosclerotic CVD and heart failure, and that it can modulated rapidly by diet within two weeks. Therefore, the purpose of this study is to better understand the role of TMAO in cardiovascular dysfunction patients with chronic kidney disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: EVOO

Other

Subjects will consume 50g of cold pressed EVOO per day for 28 days.

Other names: Dietary EVOO

Primary outcomes

  1. Serum TMAO

    Time frame: Change from baseline at four weeks

    Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)

Secondary outcomes

  1. Conduit artery endothelial function changes

    Time frame: Change from baseline at four weeks

    Conduit artery endothelial function assessed by flow mediated dilation

  2. Microvascular function change

    Time frame: Change from baseline at four weeks

    Skin blood flow response to local heating measured by laser doppler flowmetry

  3. Arterial hemodynamics changes

    Time frame: Change from baseline at four weeks

    Arterial hemodynamics derived from radial artery tonometry recordings

  4. Diastolic Function change

    Time frame: Change from baseline at four weeks

    Diastolic function at rest by echocardiography and during isometric handgrip exercise

  5. Frailty outcome hanges

    Time frame: Change from baseline at four weeks

    Frailty outcomes assessed according to Fried criteria

  6. Quality of life changes

    Time frame: Change from baseline at four weeks

    Quality of Life assessed by SF-36

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.