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

Virginia Commonwealth University (VCU) logo

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Liver Transplant

Treatments

Other: Experimental: EVOO

Study type

Interventional

Funder types

Other

Identifiers

NCT06043531
HM20027920

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

19 participants in 2 patient groups

EVOO supplementation
Experimental group
Description:
50g/day, dietary supplementation Extra Virgin Olive Oil (EVOO)
Treatment:
Other: Experimental: EVOO
Standard of Care
No Intervention group
Description:
Standard of care control

Trial contacts and locations

1

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Central trial contact

Patrice Wiecek

Data sourced from clinicaltrials.gov

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