Shear Wave Elastography

NCT04493346 | Completed

• 1 other identifier: 018-164
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 30 day in-hospital mortality rate

  30 days

• 1 year mortality rate

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Potential study participants are all adult patients in consideration for advanced HF therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White Health research institute

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Heart Failure; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amarinder Bindra, MD

  BSWHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 30, 2020
• Study Start: May 21, 2018
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)