NCT07464106 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.
| NCT ID | NCT07464106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Robert Bosch Medical Center |
| Condition | Tricuspid Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-02-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07464106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07464106 currently recruiting?
Yes, NCT07464106 is actively recruiting participants. Contact the research team at Sekretariat-Nephrologie@rbk.de for enrollment information.
Where is the NCT07464106 trial being conducted?
This trial is being conducted at Stuttgart, Germany.
Who is sponsoring the NCT07464106 clinical trial?
NCT07464106 is sponsored by Robert Bosch Medical Center. The trial plans to enroll 100 participants.