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.
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
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
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.
Cohort
Prospective
Transcatheter edge-to-edge repair (TEER)
Procedure/SurgeryRoutine intervention, observational
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)
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.
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)
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)
Change in kidney venous stasis index (KVSI)
Change in kidney venous stasis index (KVSI) measured by duplex ultrasound
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).
Hospitalizations due to heart failure
Number of hospitalizations due to worsening heart failure during the study period.
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)
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