NCT04493346

Shear Wave Elastography

Shear Wave Elastography of the Liver and Predictions of Morbidity and Mortality in Subjects Undergoing Advanced Heart Failure Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRESTUDY ASSESSMENTS Note: Assessments that are part of the standard of care and obtained within 3-4 weeks of prestudy assessment visit, are acceptable as part of the screening tests. Results of such tests will be acceptable even if obtained prior to the execution of the Informed Consent. Prior to entry into the study, the following assessments will be performed to determine if patient is eligible to continue in the study as per section 4.2 and 4.3 describing the inclusion and exclusion criteria for the study. 1. A signed Patient Informed Consent Form must be obtained. 2. A signed Patient Authorization Form (HIPAA) must be obtained. 3. It has been confirmed that the patient meets all inclusion criteria and none of the exclusion criteria. 4. Assessment of concomitant medications must be obtained within 4 weeks prior to registration. ASSESSMENTS DURING STUDY The following evaluations will be performed during the study: 1\. An assessment of liver stiffness will be performed by shear wave elastography using a Supersonic Imagine Aixplorer ShearWave™ ultrasound machine. Liver stiffness assessment will be performed at a baseline visit (i.e., before LVAD placement for those undergoing LVAD therapy), and if feasible at 1 month and 6 months post-therapy (for those undergoing advanced therapy \[i.e., LVAD or transplant\]) or at 1 month and 6 months post-baseline (for those not undergoing advanced therapy.) FOLLOW UP ASSESSMENTS The duration of patient participation in the study will be a total of 12 months, which is counted from LVAD placement (or from baseline, for those not undergoing LVAD therapy). Follow-ups will be performed at 1 month, 6 months, and 12 months, during which the following information will be documented on the CRF. Note: Patients who die or withdraw consent are considered off study and no further information will be collected.

Conditions

• Heart Failure
• Transplant; Failure, Heart
• Decompensated Heart Failure
• Fibrosis, Liver
• Cirrhosis, Liver

Timeline

• Start date: 2018-05-21
• Primary completion: 2022-04-11
• Completion: 2022-04-11
• First posted: 2020-07-30
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States