Liver TransplantNCT06043531
Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
A study testing Experimental: EVOO in people with Liver Transplant, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Experimental: EVOO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2024to 25 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18 years
- Speak and understand English
- Have received and LT
Who cannot join
- 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
Show all 9Show fewer
- Follow a vegetarian or vegan diet
- Current pregnancy
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
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. 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.
Read the 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.
- Conditions
- Liver Transplant
- Being tested
- Experimental: EVOO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: EVOOOther
Also called Dietary EVOO
Subjects will consume 50g of cold pressed EVOO per day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| EVOO supplementation | Experimental | 50g/day, dietary supplementation Extra Virgin Olive Oil (EVOO) Receives: Other: Experimental: EVOO |
| Standard of Care | No intervention | Standard of care control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum TMAO
Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)
Measured: Change from baseline at four weeks
Secondary outcomes (6)
Conduit artery endothelial function changes
Conduit artery endothelial function assessed by flow mediated dilation
Measured: Change from baseline at four weeks
Microvascular function change
Skin blood flow response to local heating measured by laser doppler flowmetry
Measured: Change from baseline at four weeks
Arterial hemodynamics changes
Arterial hemodynamics derived from radial artery tonometry recordings
Measured: Change from baseline at four weeks
Diastolic Function change
Diastolic function at rest by echocardiography and during isometric handgrip exercise
Measured: Change from baseline at four weeks
Frailty outcome hanges
Frailty outcomes assessed according to Fried criteria
Measured: Change from baseline at four weeks
Quality of life changes
Quality of Life assessed by SF-36
Measured: Change from baseline at four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Jan 2024
- Primary completion25 Oct 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Kirkman, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043531
- Sponsor's protocol ID
- HM20027920
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Trimethylamine N-Oxide for Cardiovascular Health In Liver Transplant Recipients
- ClinicalTrials.gov ID
- NCT06043531
- Acronym / sponsor ID
- HM20027920
- Conditions
- Liver Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVOO supplementation | Experimental | Other: Experimental: EVOO50g/day, dietary supplementation Extra Virgin Olive Oil (EVOO) |
| Standard of Care | No intervention | –Standard of care control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged > 18 years
- Speak and understand English
- Have received and LT
Key exclusion criteria (9 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: EVOOAlso: Dietary EVOOSubjects will consume 50g of cold pressed EVOO per day for 28 days. | Other | EVOO supplementation |
Primary outcome
Serum TMAO
Time frame: Change from baseline at four weeks
Serum TMAO levels will be assessed by nuclear magnetic resonance (NMR)
6 secondary outcomes
Conduit artery endothelial function changes
Time frame: Change from baseline at four weeks
Microvascular function change
Time frame: Change from baseline at four weeks
Arterial hemodynamics changes
Time frame: Change from baseline at four weeks
Diastolic Function change
Time frame: Change from baseline at four weeks
Frailty outcome hanges
Time frame: Change from baseline at four weeks
Quality of life changes
Time frame: Change from baseline at four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Related trials for Liver Transplant
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Kirkman principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: EVOO in people with Liver Transplant, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum TMAO (time frame: Change from baseline at four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.