Functional Tricuspid RegurgitationTRuENCT04173091
Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation
An observational study of Functional Tricuspid Regurgitation, run by Charite University, Berlin, Germany at 5 sites in 2 countries.
Trial summary
This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Tricuspid Regurgitation
- How many people
- 2,000 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Jan 2013to 30 Dec 2023
- How long will I take part?
- 10 Years
- 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: Patients with severe functional tricuspid regurgitation diagnosed echocardiographically.
Who may be able to join
- Severe functional tricuspid regurgitation
Who cannot join
- prior surgery or congenital heart diseases with involvement of the tricuspid valve
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites, 3 recruiting
- Recruiting
Brunilda Alushi
Berlin, 12200
Brunilda Alushi, MD, PhD, brunilda.alushi@charite.de
Alexander Lauten, MD
- Active, not recruiting
Contilia Heart and Vascular Centre
Essen
- Recruiting
Department of Internal Medicine and Cardiology, Heart Centre Leipzig
Leipzig
Philipp Lurz, MD, philipp.lurz@medizin.uni-leipzig.de
- Recruiting
German Heart Centre
Munich
Erjon Xhepa, MD, PhD, xhepa@dhm.mhn.de
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Centre
Tel Aviv, Petah Tikva, 49100
Ran Kornowski, MD, ran.kornowski@gmail.com
About this study
Official title: Risk Stratification in Patients With Severe Tricuspid Regurgitation: Insights From the TRicuspid Regurgitation rEgistry (TRuE)
This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.
- Conditions
- Functional Tricuspid Regurgitation
- Being tested
- No Intervention
- Keywords
- tricuspid regurgitation, tricuspid valve, percutaneous treatment, right ventricle
- 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.
No InterventionDiagnostic test
No Intervention planed
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Mortality due to all causes
Measured: 1 year
All-cause mortality
Mortality due to all causes
Measured: 5 years
All-cause mortality
Mortality due to all causes
Measured: 10 years
Secondary outcomes (7)
Cardiovascular mortality
Mortality due to cardiovascular causes
Measured: 1 year
Cardiovascular mortality
Mortality due to cardiovascular causes
Measured: 5 years
Cardiovascular mortality
Mortality due to cardiovascular causes
Measured: 10 years
Number of hospitalizations
Number of hospitalizations due to right heart failure
Measured: 1 year
Number of hospitalizations
Number of hospitalizations due to right heart failure
Measured: 2 years
Number of hospitalizations
Number of hospitalizations due to right heart failure
Measured: 5 years
Number of hospitalizations
Number of hospitalizations due to right heart failure
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Jan 2013
- Primary completion31 Dec 2017
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Lauten, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173091
- Sponsor's protocol ID
- TRuE012013
- Acronym
- TRuE
- Status last verified
- Mar 2020
- First submitted
- 16 Nov 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification in Patients With Severe Tricuspid Regurgitation: Insights From the TRicuspid Regurgitation rEgistry (TRuE)
- ClinicalTrials.gov ID
- NCT04173091
- Acronym / sponsor ID
- TRuE / TRuE012013
- Conditions
- Functional Tricuspid Regurgitation
- Keywords
- tricuspid regurgitation, tricuspid valve, percutaneous treatment, right ventricle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 21 Nov 2019 (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.
This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe functional tricuspid regurgitation diagnosed echocardiographically.
Key inclusion criteria (1 listed)
- Severe functional tricuspid regurgitation
Key exclusion criteria (1 listed)
- prior surgery or congenital heart diseases with involvement of the tricuspid valve
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 |
|---|---|---|
| No InterventionNo Intervention planed | Diagnostic test | – |
Primary outcome
All-cause mortality
Time frame: 1 year
Mortality due to all causes
All-cause mortality
Time frame: 5 years
Mortality due to all causes
All-cause mortality
Time frame: 10 years
Mortality due to all causes
7 secondary outcomes
Cardiovascular mortality
Time frame: 1 year
Cardiovascular mortality
Time frame: 5 years
Cardiovascular mortality
Time frame: 10 years
Number of hospitalizations
Time frame: 1 year
Number of hospitalizations
Time frame: 2 years
Number of hospitalizations
Time frame: 5 years
Number of hospitalizations
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Functional Tricuspid Regurgitation
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
Recruiting
Safety and Feasibility Study: Transcatheter Valve Repair in Severe Symptomatic Functional Tricuspid Regurgitation
Tricuspid Regurgitation Functional, Tricuspid Regurgitation (TR)
Active, not recruitingObservational study
Transcatheter Repair of Tricuspid Regurgitation With Edwards Cardioband TR System Post Market Study (TriBAND)
Tricuspid Regurgitation, Tricuspid Insufficiency
RecruitingObservational study
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Pacemaker-Induced Cardiomyopathy, Tricuspid 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.
Department of Internal Medicine and Cardiology, Heart Centre Leipzig
Leipzig, Germany
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Tricuspid Regurgitation, run by Charite University, Berlin, Germany at 5 sites in 2 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 1 year). The study lists 3 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 27 Mar 2020.