Status:
COMPLETED
Shear Wave Elastography
Lead Sponsor:
Baylor Research Institute
Conditions:
Heart Failure
Transplant; Failure, Heart
Eligibility:
All Genders
18+ years
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, predic...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04493346
Start Date
May 21 2018
End Date
April 11 2022
Last Update
January 26 2023
Active Locations (1)
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1
Baylor Scott & White Health research institute
Dallas, Texas, United States, 75246