Evaluation of the Impact of Interventional Treatments for Symptomatic, Severe Tricuspid Valve Ins… (NCT07464106) | Clinical Trial Compass
RecruitingNot Applicable
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.
Germany100 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in estimated glomerular filtration rate (eGFR) slope
Timeframe: Baseline, 6 months, 12 months, and 24 months
2
Incidence of acute kidney injury (AKI)
Timeframe: Baseline, 6 months, 12 months, and 24 months
3
Physical activity assessed using the activPAL4 micro activity monitor
Timeframe: Baseline, 6 months, 12 months, and 24 months
4
Change in functional exercise capacity assessed with the 6-minute walk test (6MWT)
Timeframe: Baseline, 6 months, 12 months, and 24 months