Tricuspid Valve InsufficiencyNCT03166488
MRE Evaluation of Liver Stiffness After Tricuspid Valvular Repair
A study testing MRI in people with Tricuspid Valve Insufficiency, run by Mayo Clinic.
Trial summary
The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to Dec 2018
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary tricuspid valvular regurgitation (tricuspid valve disease not related to a left-sided cardiac abnormality) diagnosed by echocardiography
- Evidence of passive hepatic congestion. Patients with severe tricuspid regurgitation diagnosed at echocardiography will constitute evidence of passive hepatic congestion.
- Patient scheduled for surgical tricuspid valvular repair or replacement.
Who cannot join
- Contraindication for MRI (implantable devices such as cardiac pacemaker, anxiety, inability to lay supine, etc).
- Additional conditions which may elevate their liver stiffness: hepatic fibrosis or cirrhosis, hepatic parenchymal disease (primary biliary cirrhosis, primary sclerosing cholangitis, etc), acute or chronic hepatitis (viral, substance or medication induced), disorders of hepatic vasculature, biliary obstruction or disease, primary or metastatic hepatic malignancy.
- Cannot agree to return for a follow up visit to complete the postsurgical imaging.
About this study
Official title: Evaluation of Liver Stiffness After Tricuspid Valvular Repair Using Magnetic Resonance Elastography
The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may lead to cirrhosis and its related complications. The increased liver stiffness may be due to a poorly functioning tricuspid valve. With this research, the investigators will be able to determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- MRI
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE).
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid Valvular Repair Patients | Experimental | Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE) within 1 month preoperatively and as close to 6 months postoperatively as reasonably achievable. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver stiffness between preoperative and postoperative MR elastography (MRE)
Increased liver stiffness often means there is chronic liver disease and fibrosis.
Measured: baseline, approximately 6 months postoperatively
Change in tricuspid valve regurgitation measured by echocardiography
Increased liver stiffness may be due to a poorly functioning tricuspid valve.
Measured: baseline, approximately 6 months postoperatively
Secondary outcomes (1)
Change in Subject Functional Capacity
Subject Functional Capacity will be measured by the Self Assessment New York Heart Association (NYHA) Classification Scale. This questionnaire consists of 4 questions regarding the subject's ability to carry on physical activities. NYHA Class I = no symptoms in regular activity; NYHA Class II = Mild symptoms and slight limitation; NYHA Class III = noticeable limitations even during minimal activity; NYHA Class IV = severe limitations even while at rest.
Measured: baseline, approximately 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 May 2017
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael L Wells, Mayo Clinic
- Investigators
- Michael L Wells, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166488
- Sponsor's protocol ID
- 16-009548
- Status last verified
- Jun 2018
- First submitted
- 19 May 2017
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Stiffness After Tricuspid Valvular Repair Using Magnetic Resonance Elastography
- ClinicalTrials.gov ID
- NCT03166488
- Acronym / sponsor ID
- 16-009548
- Conditions
- Tricuspid Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 May 2017 (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.
The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may lead to cirrhosis and its related complications. The increased liver stiffness may be due to a poorly functioning tricuspid valve. With this research, the investigators will be able to determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tricuspid Valvular Repair Patients | Experimental | Device: MRISubjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE) within 1 month preoperatively and as close to 6 months postoperatively as reasonably achievable. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary tricuspid valvular regurgitation (tricuspid valve disease not related to a left-sided cardiac abnormality) diagnosed by echocardiography
- Evidence of passive hepatic congestion. Patients with severe tricuspid regurgitation diagnosed at echocardiography will constitute evidence of passive hepatic congestion.
- Patient scheduled for surgical tricuspid valvular repair or replacement.
Key exclusion criteria (3 listed)
- Contraindication for MRI (implantable devices such as cardiac pacemaker, anxiety, inability to lay supine, etc).
- Additional conditions which may elevate their liver stiffness: hepatic fibrosis or cirrhosis, hepatic parenchymal disease (primary biliary cirrhosis, primary sclerosing cholangitis, etc), acute or chronic hepatitis (viral, substance or medication induced), disorders of hepatic vasculature, biliary obstruction or disease, primary or metastatic hepatic malignancy.
- Cannot agree to return for a follow up visit to complete the postsurgical imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRISubjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE). | Device | Tricuspid Valvular Repair Patients |
Primary outcome
Change in liver stiffness between preoperative and postoperative MR elastography (MRE)
Time frame: baseline, approximately 6 months postoperatively
Increased liver stiffness often means there is chronic liver disease and fibrosis.
Change in tricuspid valve regurgitation measured by echocardiography
Time frame: baseline, approximately 6 months postoperatively
Increased liver stiffness may be due to a poorly functioning tricuspid valve.
1 secondary outcome
Change in Subject Functional Capacity
Time frame: baseline, approximately 6 months postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Tricuspid Valve Insufficiency
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Not yet recruiting
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
Aortic Stenosis, Mitral Regurgitation
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
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.
Michael L Wells principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Tricuspid Valve Insufficiency, run by Mayo Clinic.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in liver stiffness between preoperative and postoperative MR elastography (MRE) (time frame: baseline, approximately 6 months postoperatively). The study lists 2 primary outcomes in all. 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 13 Jun 2018.