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

Liver Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043531
• Other study ID #: HM20027920
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: September 15, 2025

Study information

• Verified date: March 2024
• Source: Virginia Commonwealth University
• Contact: Patrice Wiecek
• Phone: (804) 827-1815
• Email: wiecekpj[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Other:
• Experimental: EVOO
Subjects will consume 50g of cold pressed EVOO per day for 28 days.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum TMAO	Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)	Change from baseline at four weeks
Secondary	Conduit artery endothelial function changes	Conduit artery endothelial function assessed by flow mediated dilation	Change from baseline at four weeks
Secondary	Microvascular function change	Skin blood flow response to local heating measured by laser doppler flowmetry	Change from baseline at four weeks
Secondary	Arterial hemodynamics changes	Arterial hemodynamics derived from radial artery tonometry recordings	Change from baseline at four weeks
Secondary	Diastolic Function change	Diastolic function at rest by echocardiography and during isometric handgrip exercise	Change from baseline at four weeks
Secondary	Frailty outcome hanges	Frailty outcomes assessed according to Fried criteria	Change from baseline at four weeks
Secondary	Quality of life changes	Quality of Life assessed by SF-36	Change from baseline at four weeks