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

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ClinicalTrials.gov Identifier: NCT06043531
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Liver Transplant Other: Experimental: EVOO Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
Actual Study Start Date : January 18, 2024
Estimated Primary Completion Date : September 15, 2025
Estimated Study Completion Date : September 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EVOO supplementation
50g/day, dietary supplementation Extra Virgin Olive Oil (EVOO)
 Other: Experimental: EVOO
Subjects will consume 50g of cold pressed EVOO per day for 28 days.
Other Name: Dietary EVOO
No Intervention: Standard of Care
Standard of care control


Outcome Measures
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Primary Outcome Measures :
  1. Serum TMAO [ Time Frame: Change from baseline at four weeks ]
    Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043531


Contacts
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Contact: Patrice Wiecek (804) 827-1815 wiecekpj@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Danielle Kirkman       dlkirkman@vcu.edu   
Contact: Patrice Wiecek       wiecekpj@vcu.edu   
Principal Investigator: Danielle Kirkman         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Danielle Kirkman Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT06043531    
Other Study ID Numbers: HM20027920
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No