Heart Failure Clinical Trial
Official title:
Shear Wave Elastography of the Liver and Predictions of Morbidity and Mortality in Subjects Undergoing Advanced Heart Failure Therapy
NCT number | NCT04493346 |
Other study ID # | 018-164 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 21, 2018 |
Est. completion date | April 11, 2022 |
Verified date | January 2023 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In individuals needing a left ventricular assist device (LVAD), right heart failure (RHF) is a serious complication post-surgery, associated with worsened outcomes including mortality. However, predictors of decompensation after LVAD are not well established. Liver dysfunction pre-LVAD has been shown to be associated with poor outcomes post-LVAD, but the interplay between liver abnormalities and RHF post-LVAD is not well characterized. Liver stiffness (LS) is a measure associated with certain types of liver abnormalities (e.g., liver fibrosis; cirrhosis). Thus, we hypothesize that elevated LS measured by SWE is associated with increased morbidity and mortality in patients undergoing LVAD implantation and yields increased need for advanced postoperative HF therapies including the use of right ventricular assist devices (RVAD) for the management of RHF.
Status | Completed |
Enrollment | 14 |
Est. completion date | April 11, 2022 |
Est. primary completion date | April 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female or male patients =18 years of age. - Patient must be diagnosed with HF. - Patient must be referred for an evaluation for advanced HF therapy (i.e., LVAD or heart transplantation). - Patient must be accessible for treatment and follow-up. - Outpatients only - All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry. Exclusion Criteria: - Severe obesity (body mass index [BMI] >35 kg/m2) or severe abdominal obesity - History of chronic or acute liver disease. - Positive test for hepatitis C antibody or hepatitis B surface antigen reactivity - History of intravenous drug or heavy alcohol use - Patients with ultrasound data showing liver surface nodularity as a surrogate for advanced fibrosis. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor Scott & White Health research institute | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver stiffness (LS) measurements with development of post-LVAD RHF. | An assessment of liver stiffness will be performed by shear wave elastography using a Supersonic Imagine Aixplorer ShearWave™ ultrasound machine. | 24 months | |
Secondary | 30 day in-hospital mortality rate | We will perform logistic regression to determine the optimal cutpoint of LS to predict mortality at a given time point, provided the sample size is adequate. | 30 days | |
Secondary | 1 year mortality rate | We will perform logistic regression to determine the optimal cutpoint of LS to predict mortality at a given time point, provided the sample size is adequate. | 1 year |
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