Heart FailureNCT04493346
Shear Wave Elastography
An observational study of Heart Failure and Transplant; Failure, Heart, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Transplant; Failure, Heart, Decompensated Heart Failure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 11 Apr 2022
- Phase
- Observational
- 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
Study population: Potential study participants are all adult patients in consideration for advanced HF therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott & White Health research institute
Dallas, Texas, 75246
About this study
Official title: Shear Wave Elastography of the Liver and Predictions of Morbidity and Mortality in Subjects Undergoing Advanced Heart Failure Therapy
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.
Read the 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.
- A signed Patient Informed Consent Form must be obtained.
- A signed Patient Authorization Form (HIPAA) must be obtained.
- It has been confirmed that the patient meets all inclusion criteria and none of the exclusion criteria.
- 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:
- 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
- Medical subject headings
- Heart Failure, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 30 days
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start21 May 2018
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amarinder Bindra, MD, Principal investigator, BSWHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493346
- Sponsor's protocol ID
- 018-164
- Status last verified
- Jan 2023
- First submitted
- 13 Jul 2020
- Last updated
- 26 Jan 2023
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography of the Liver and Predictions of Morbidity and Mortality in Subjects Undergoing Advanced Heart Failure Therapy
- ClinicalTrials.gov ID
- NCT04493346
- Acronym / sponsor ID
- 018-164
- Conditions
- Heart Failure, Transplant; Failure, Heart, Decompensated Heart Failure, Fibrosis, Liver, Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 30 Jul 2020 (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.
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.
- A signed Patient Informed Consent Form must be obtained.
- A signed Patient Authorization Form (HIPAA) must be obtained.
- It has been confirmed that the patient meets all inclusion criteria and none of the exclusion criteria.
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential study participants are all adult patients in consideration for advanced HF therapy.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver stiffness (LS) measurements with development of post-LVAD RHF.
Time frame: 24 months
An assessment of liver stiffness will be performed by shear wave elastography using a Supersonic Imagine Aixplorer ShearWave™ ultrasound machine.
2 secondary outcomes
30 day in-hospital mortality rate
Time frame: 30 days
1 year mortality rate
Time frame: 1 year
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 26 Jan 2023.
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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.
Amarinder Bindra, MD principal investigator
BSWHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Transplant; Failure, Heart, run by Baylor Research Institute 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 6 inclusion and 5 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 26 Jan 2023. 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?
Liver stiffness (LS) measurements with development of post-LVAD RHF. (time frame: 24 months). 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 26 Jan 2023.