Tricuspid RegurgitationNCT04570098
Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
An observational study of Tricuspid Regurgitation and Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Tricuspid Regurgitation, Heart Failure
- How many people
- 1,016 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jul 2020to 30 Sep 2024
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population include patients with heart failure (all three entities). All patients will be examined with an echocardiography at the Charité, followed by long-term observation to assess the prognostic relevance of tricuspid regurgitation in heart failure.
Who may be able to join
- Patients with transthoracic echocardiography (TTE) and heart failure
- Reported heart failure symptoms within the last two years
- >18 years
- Written, documented consent
Who cannot join
- Patients in care or unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy options.
Read the detailed description
Moderate to severe tricuspid regurgitation (TR) is a frequent result of left heart failure causing a limiting prognosis. The new interventional therapies have given more relevance to the questions of the prognostic significance of severe TR in the various heart failure entities.
Important but currently unanswered questions for the establishment of successful, interventional therapies of TR are:
- What effect does TR have on patients with heart failure?
- Which patients at which stage of the disease benefit from interventional TR-therapies? In order to answer these questions, the aim of the study is to prospectively record the prevalence of TR (including quantification) in all heart failure patients at the Charité, followed by long-term observation to assess its prognostic relevance.
In addition to answering the above-mentioned questions, the project will allow a central registration of all symptomatic heart failure patients. A comparative outcome analysis per propensity score matching with the untreated patients of the registry would allow to give first considerations which patients are ideal candidates for interventional therapies.
Primary endpoint: death Secondary endpoint: hospitalization due to cardiac decompensation, exercise capacity according to NYHA classification
- Conditions
- Tricuspid Regurgitation, Heart Failure
- Medical subject headings
- Tricuspid Valve Insufficiency, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
Overall mortality after 3 months (number of deceased patients)
Measured: 3 months after enrolment
Overall mortality
Overall mortality after 24 months (number of deceased patients)
Measured: 24 months after enrolment
Secondary outcomes (4)
hospitalization due to cardiac decompensation
number of hospitalized patients after 3 months
Measured: 3 months after enrolment
exercise capacity according to NYHA classification
Measured: 3 months after enrolment
hospitalization due to cardiac decompensation
number of hospitalized patients after 24 months
Measured: 24 months after enrolment
exercise capacity according to NYHA classification
Measured: 24 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start26 Jul 2020
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Henryk Dreger, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570098
- Sponsor's protocol ID
- EA1/178/19
- Status last verified
- Feb 2025
- First submitted
- 20 Sep 2020
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the expected publications, it is planned to provide data of the study participants and more detailed information on inclusion and exclusion criteria (study protocol).
Publications
Mattig I, Romero Dorta E, Frumkin D, Kretzschmar H, Sommer A, Redel AM, Buchstaller J, Sanchez Gomez OJ, Pieske-Kraigher E, Stegherr R, Stangl K, Hindricks G, Dreger H. Sex differences in the prevalence and prognosis of tricuspid regurgitation among patients with heart failure. Heart. 2026 Feb 12;112(5):285-292. doi: 10.1136/heartjnl-2025-325913.
PubMed 40707240
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Prognostic Relevance of Tricuspid Regurgitation in Different Heart Failure Entities
- ClinicalTrials.gov ID
- NCT04570098
- Acronym / sponsor ID
- EA1/178/19
- Conditions
- Tricuspid Regurgitation, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 26 Jul 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 30 Sep 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.
The present study includes patients with tricuspid regurgitation and heart failure diagnosed with echocardiography. The aim is to evaluate the physical performance of patients with tricuspid regurgitation and heart failure, to observe the course of the diseases and to allow a better understanding of new therapy options.
Detailed description
Moderate to severe tricuspid regurgitation (TR) is a frequent result of left heart failure causing a limiting prognosis. The new interventional therapies have given more relevance to the questions of the prognostic significance of severe TR in the various heart failure entities.
Important but currently unanswered questions for the establishment of successful, interventional therapies of TR are:
- What effect does TR have on patients with heart failure?
- Which patients at which stage of the disease benefit from interventional TR-therapies? In order to answer these questions, the aim of the study is to prospectively record the prevalence of TR (including quantification) in all heart failure patients at the Charité, followed by long-term observation to assess its prognostic relevance.
In addition to answering the above-mentioned questions, the project will allow a central registration of all symptomatic heart failure patients. A comparative outcome analysis per propensity score matching with the untreated patients of the registry would allow to give first considerations which patients are ideal candidates for interventional therapies.
Primary endpoint: death Secondary endpoint: hospitalization due to cardiac decompensation, exercise capacity according to NYHA classification
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population include patients with heart failure (all three entities). All patients will be examined with an echocardiography at the Charité, followed by long-term observation to assess the prognostic relevance of tricuspid regurgitation in heart failure.
Key inclusion criteria (4 listed)
- Patients with transthoracic echocardiography (TTE) and heart failure
- Reported heart failure symptoms within the last two years
- >18 years
- Written, documented consent
Key exclusion criteria (1 listed)
- Patients in care or unable to consent
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
Overall mortality
Time frame: 3 months after enrolment
Overall mortality after 3 months (number of deceased patients)
Overall mortality
Time frame: 24 months after enrolment
Overall mortality after 24 months (number of deceased patients)
4 secondary outcomes
hospitalization due to cardiac decompensation
Time frame: 3 months after enrolment
exercise capacity according to NYHA classification
Time frame: 3 months after enrolment
hospitalization due to cardiac decompensation
Time frame: 24 months after enrolment
exercise capacity according to NYHA classification
Time frame: 24 months after enrolment
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 12 Feb 2025.
- Derived from this study: PubMed 40707240Mattig I, Romero Dorta E, Frumkin D, Kretzschmar H, Sommer A, Redel AM, Buchstaller J, Sanchez Gomez OJ, Pieske-Kraigher E, Stegherr R, Stangl K, Hindricks G, Dreger H. Sex differences in the prevalence and prognosis of tricuspid regurgitation among patients with heart failure. Heart. 2026 Feb 12;112(5):285-292. doi: 10.1136/heartjnl-2025-325913.
- Individual participant dataSharing planned: Yes. As part of the expected publications, it is planned to provide data of the study participants and more detailed information on inclusion and exclusion criteria (study protocol).
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tricuspid Regurgitation and Heart Failure, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 12 Feb 2025. 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 Germany. 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?
Overall mortality (time frame: 3 months after enrolment). 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?
On the ClinicalTrials.gov record for NCT04570098, which also lists 1 linked publication.
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 12 Feb 2025.