Liver Transplant
Conditions
Brief 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.
Detailed 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.
Interventions
OTHERExperimental: EVOO
Subjects will consume 50g of cold pressed EVOO per day for 28 days.
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum TMAO | Change from baseline at four weeks | Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conduit artery endothelial function changes | Change from baseline at four weeks | Conduit artery endothelial function assessed by flow mediated dilation |
| Microvascular function change | Change from baseline at four weeks | Skin blood flow response to local heating measured by laser doppler flowmetry |
| Arterial hemodynamics changes | Change from baseline at four weeks | Arterial hemodynamics derived from radial artery tonometry recordings |
| Diastolic Function change | Change from baseline at four weeks | Diastolic function at rest by echocardiography and during isometric handgrip exercise |
| Frailty outcome hanges | Change from baseline at four weeks | Frailty outcomes assessed according to Fried criteria |
| Quality of life changes | Change from baseline at four weeks | Quality of Life assessed by SF-36 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDanielle Kirkman
Virginia Commonwealth University
Outcome results
None listed