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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEER-Group | Tricuspid regurgitation group prior to intervention and after intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter edge-to-edge repair (TEER) | Procedure | Routine intervention, observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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) | 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) | Baseline, 6 months, 12 months, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in kidney venous stasis index (KVSI) | Change in kidney venous stasis index (KVSI) measured by duplex ultrasound | Baseline, 6 months, 12 months, and 24 months |
| Change in body mass index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Schwab | Contact | 071181010 | Sekretariat-Nephrologie@rbk.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Bosch Hospital | Recruiting | Stuttgart | Germany |
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Change in body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²).
| 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. | 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) | 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. | 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) | 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). | 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. | 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) | 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. | Baseline, 6 months, 12 months, and 24 months |
| Incidence of dialysis initiation | Initiation of chronic renal replacement therapy (hemodialysis or peritoneal dialysis) | Baseline, 6 months, 12 months, and 24 months |
| All-cause mortality | Death from any cause during the study period | 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) | 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) | 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. | 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 | Baseline, 6 months, 12 months, and 24 months |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D059347 | Cardio-Renal Syndrome |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006333 | Heart Failure |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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