Tricuspid RegurgitationTriRenGeNCT07464106
Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.
An observational study of Tricuspid Regurgitation and Tricuspid Valve Insufficiency, run by Robert Bosch Medical Center at 1 site in Germany.
Trial summary
The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Cardio-Renal Syndrome
- What is being tested?
- Transcatheter edge-to-edge repair (TEER)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population includes adult patients with severe symptomatic tricuspid valve insufficiency who are referred for TriClip/TricValve screening and are aged 18 years or older. Participants must be able to provide informed consent and have the capacity to walk short distances with the aid of mobility devices. Exclusion criteria include dialysis-dependent or terminal kidney disease, inability to comply with study-related assessments (e.g., due to dementia or cognitive decline), severe anemia (Hb <7 g/dl), and the need for a tricuspid valve intervention with palliative intent, with a likely imminent death. Additionally, patients who are unable or unwilling to provide informed consent will be excluded from the study. This population represents individuals who are eligible for the intervention, while the exclusions ensure that participants can meaningfully engage in the study assessments and outcomes.
Who may be able to join
- Severe symptomatic tricuspid valve insufficiency and referral for TriClip/TricValve screening
- Completed 18th year of life
- Ability to consent
- Able to walk short distances with aids
Who cannot join
- Dialysis-dependent/terminal kidney disease
- Inability to comply with study-associated assessments (e.g., existing dementia)
- Severe anemia (Hb <7 g/dl)
- Tricuspid valve intervention with palliative intent and likely imminent death
- Lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Robert Bosch Hospital
Stuttgart
Andrea Schwab, 0711/8101-0, Sekretariat-Nephrologie@rbk.de
About this study
The hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in patients. Additionally, the study will assess the impact of the intervention on functional parameters such as motor capacity, physical activity, performance of activities of daily living, and ultimately, participation and quality of life.
- Being tested
- Transcatheter edge-to-edge repair (TEER)
- Medical subject headings
- Tricuspid Valve Insufficiency, Cardio-Renal Syndrome, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter edge-to-edge repair (TEER)Procedure or surgery
Routine intervention, observational
| Study group | Role | What they receive |
|---|---|---|
| TEER-Group | Tricuspid regurgitation group prior to intervention and after intervention Receives: Procedure: Transcatheter edge-to-edge repair (TEER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration rate (eGFR) slope
Annual change in estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation based on serial serum creatinine measurements (ml/min/1.73m² per year)
Measured: Baseline, 6 months, 12 months, and 24 months
Incidence of acute kidney injury (AKI)
Occurrence of acute kidney injury defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria based on changes in serum creatinine.
Measured: Baseline, 6 months, 12 months, and 24 months
Physical activity assessed using the activPAL4 micro activity monitor
Physical activity measured over a 7-day monitoring period using the activPAL4 micro activity monitor (PAL Technologies, Glasgow, UK)
Measured: Baseline, 6 months, 12 months, and 24 months
Change in functional exercise capacity assessed with the 6-minute walk test (6MWT)
Change in functional exercise capacity measured by the 6-minute walk test (6MWT)
Measured: Baseline, 6 months, 12 months, and 24 months
Secondary outcomes (16)
Change in kidney venous stasis index (KVSI)
Change in kidney venous stasis index (KVSI) measured by duplex ultrasound
Measured: Baseline, 6 months, 12 months, and 24 months
Change in body mass index (BMI)
Change in body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²).
Measured: Baseline, 6 months, 12 months, and 24 months
Hospitalizations due to heart failure
Number of hospitalizations due to worsening heart failure during the study period.
Measured: Baseline, 6 months, 12 months, and 24 months
Change in disease-specific quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Change in disease-specific quality of life measured using the Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)
Measured: Baseline, 6 months, 12 months, and 24 months
Change in independence in activities of daily living assessed with the Katz Index
Change in independence in activities of daily living measured using the Katz Index.
Measured: Baseline, 6 months, 12 months, and 24 months
Change in frailty assessed using the Clinical Frailty Scale (CFS)
Change in frailty status measured using the Clinical Frailty Scale (CFS)
Measured: Baseline, 6 months, 12 months, and 24 months
Change in hand grip strength measured using a Jamar dynamometer
Change in muscle strength assessed by hand grip strength using a manual dynamometer (Jamar).
Measured: Baseline, 6 months, 12 months, and 24 months
Change in functional mobility assessed with the Timed Up and Go Test (TUG)
Change in functional mobility measured using the Timed Up and Go Test (TUG), assessing the time required to stand up, walk three meters, turn, return, and sit down.
Measured: Baseline, 6 months, 12 months, and 24 months
Change in urinary albumin-to-creatinine ratio (UACR)
Change in albuminuria measured as urinary albumin-to-creatinine ratio (UACR) in spot urine samples (mg/gCreatinine)
Measured: Baseline, 6 months, 12 months, and 24 months
Prevalence of chronic kidney disease (CKD)
Presence of chronic kidney disease defined according to KDIGO criteria based on estimated glomerular filtration rate (eGFR) and markers of kidney damage.
Measured: Baseline, 6 months, 12 months, and 24 months
Incidence of dialysis initiation
Initiation of chronic renal replacement therapy (hemodialysis or peritoneal dialysis)
Measured: Baseline, 6 months, 12 months, and 24 months
All-cause mortality
Death from any cause during the study period
Measured: Baseline, 6 months, 12 months, and 24 months
Change in cognitive function assessed with the Blessed Orientation-Memory-Concentration Test (BOMCT)
Change in cognitive function measured using the Blessed Orientation-Memory-Concentration Test (BOMCT)
Measured: Baseline, 6 months, 12 months, and 24 months
Change in emotional well-being assessed with the "Allgemeine Depressionsskala" short form (ADS-K)
Change in depressive symptoms assessed using the short version of the general depression scale (ADS-K)
Measured: Baseline, 6 months, 12 months, and 24 months
Change in body composition measured by bioelectrical impedance analysis (BIA)
Change in body composition assessed by bioelectrical impedance analysis using the AKERN BIA 101 device.
Measured: Baseline, 6 months, 12 months, and 24 months
Change in Venous Excess Ultrasound (VExUS) Score
Change in VExUS Score (bedside ultrasound-based approach with a more comprehensive assessment of venous congestion) measured by duplex ultrasound
Measured: Baseline, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start1 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Bosch Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moritz Schanz, Robert Bosch Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464106
- Sponsor's protocol ID
- S 848
- Acronym
- TriRenGe
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2025
- Last updated
- 11 Mar 2026
- Results posted
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Insufficiency on Renal Integrity and Function, as Well as on Physical Function and Activity in Older Adults.
- ClinicalTrials.gov ID
- NCT07464106
- Acronym / sponsor ID
- TriRenGe / S 848
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Robert Bosch Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Mar 2026 (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 hypothesis is that renal function will improve following tricuspid valve intervention. A reduction in renal biomarkers is also expected. Furthermore, based on previous assessments, it is anticipated that there will be an improvement in volume status (reduced edema), symptom burden, and physical capacity in patients. Additionally, the study will assess the impact of the intervention on functional parameters such as motor capacity, physical activity, performance of activities of daily living, and ultimately, participation and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEER-Group | – | Procedure: Transcatheter edge-to-edge repair (TEER)Tricuspid regurgitation group prior to intervention and after intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients with severe symptomatic tricuspid valve insufficiency who are referred for TriClip/TricValve screening and are aged 18 years or older. Participants must be able to provide informed consent and have the capacity to walk short distances with the aid of mobility devices. Exclusion criteria include dialysis-dependent or terminal kidney disease, inability to comply with study-related assessments (e.g., due to dementia or cognitive decline), severe anemia (Hb <7 g/dl), and the need for a tricuspid valve intervention with palliative intent, with a likely imminent death. Additionally, patients who are unable or unwilling to provide informed consent will be excluded from the study. This population represents individuals who are eligible for the intervention, while the exclusions ensure that participants can meaningfully engage in the study assessments and outcomes.
Key inclusion criteria (4 listed)
- Severe symptomatic tricuspid valve insufficiency and referral for TriClip/TricValve screening
- Completed 18th year of life
- Ability to consent
- Able to walk short distances with aids
Key exclusion criteria (5 listed)
- Dialysis-dependent/terminal kidney disease
- Inability to comply with study-associated assessments (e.g., existing dementia)
- Severe anemia (Hb <7 g/dl)
- Tricuspid valve intervention with palliative intent and likely imminent death
- Lack of consent
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 |
|---|---|---|
| Transcatheter edge-to-edge repair (TEER)Routine intervention, observational | Procedure or surgery | TEER-Group |
Primary outcome
Change in estimated glomerular filtration rate (eGFR) slope
Time frame: Baseline, 6 months, 12 months, and 24 months
Annual change in estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation based on serial serum creatinine measurements (ml/min/1.73m² per year)
Incidence of acute kidney injury (AKI)
Time frame: Baseline, 6 months, 12 months, and 24 months
Occurrence of acute kidney injury defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria based on changes in serum creatinine.
Physical activity assessed using the activPAL4 micro activity monitor
Time frame: Baseline, 6 months, 12 months, and 24 months
Physical activity measured over a 7-day monitoring period using the activPAL4 micro activity monitor (PAL Technologies, Glasgow, UK)
Change in functional exercise capacity assessed with the 6-minute walk test (6MWT)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in functional exercise capacity measured by the 6-minute walk test (6MWT)
16 secondary outcomes
Change in kidney venous stasis index (KVSI)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in body mass index (BMI)
Time frame: Baseline, 6 months, 12 months, and 24 months
Hospitalizations due to heart failure
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in disease-specific quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in independence in activities of daily living assessed with the Katz Index
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in frailty assessed using the Clinical Frailty Scale (CFS)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in hand grip strength measured using a Jamar dynamometer
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in functional mobility assessed with the Timed Up and Go Test (TUG)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in urinary albumin-to-creatinine ratio (UACR)
Time frame: Baseline, 6 months, 12 months, and 24 months
Prevalence of chronic kidney disease (CKD)
Time frame: Baseline, 6 months, 12 months, and 24 months
Incidence of dialysis initiation
Time frame: Baseline, 6 months, 12 months, and 24 months
All-cause mortality
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in cognitive function assessed with the Blessed Orientation-Memory-Concentration Test (BOMCT)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in emotional well-being assessed with the "Allgemeine Depressionsskala" short form (ADS-K)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in body composition measured by bioelectrical impedance analysis (BIA)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in Venous Excess Ultrasound (VExUS) Score
Time frame: Baseline, 6 months, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Tricuspid Valve Insufficiency, run by Robert Bosch Medical Center 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 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Schwab (071181010, Sekretariat-Nephrologie@rbk.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated glomerular filtration rate (eGFR) slope (time frame: Baseline, 6 months, 12 months, and 24 months). The study lists 4 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 11 Mar 2026.