Cardio-Renal Syndrome, Frailty, Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Conditions
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.
Interventions
Routine intervention, observational
Sponsors
Robert Bosch Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) slope | 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) | 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 | 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) | Baseline, 6 months, 12 months, and 24 months | Change in functional exercise capacity measured by the 6-minute walk test (6MWT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in kidney venous stasis index (KVSI) | Baseline, 6 months, 12 months, and 24 months | Change in kidney venous stasis index (KVSI) measured by duplex ultrasound |
| Change in body mass index (BMI) | Baseline, 6 months, 12 months, and 24 months | Change in body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²). |
| Hospitalizations due to heart failure | Baseline, 6 months, 12 months, and 24 months | 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) | Baseline, 6 months, 12 months, and 24 months | Change in disease-specific quality of life measured using the Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12) |
| Change in independence in activities of daily living assessed with the Katz Index | Baseline, 6 months, 12 months, and 24 months | Change in independence in activities of daily living measured using the Katz Index. |
| Change in frailty assessed using the Clinical Frailty Scale (CFS) | Baseline, 6 months, 12 months, and 24 months | Change in frailty status measured using the Clinical Frailty Scale (CFS) |
| Change in hand grip strength measured using a Jamar dynamometer | Baseline, 6 months, 12 months, and 24 months | Change in muscle strength assessed by hand grip strength using a manual dynamometer (Jamar). |
| Change in functional mobility assessed with the Timed Up and Go Test (TUG) | Baseline, 6 months, 12 months, and 24 months | 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. |
| Change in urinary albumin-to-creatinine ratio (UACR) | Baseline, 6 months, 12 months, and 24 months | Change in albuminuria measured as urinary albumin-to-creatinine ratio (UACR) in spot urine samples (mg/gCreatinine) |
| Prevalence of chronic kidney disease (CKD) | Baseline, 6 months, 12 months, and 24 months | Presence of chronic kidney disease defined according to KDIGO criteria based on estimated glomerular filtration rate (eGFR) and markers of kidney damage. |
| Incidence of dialysis initiation | Baseline, 6 months, 12 months, and 24 months | Initiation of chronic renal replacement therapy (hemodialysis or peritoneal dialysis) |
| All-cause mortality | Baseline, 6 months, 12 months, and 24 months | Death from any cause during the study period |
| Change in cognitive function assessed with the Blessed Orientation-Memory-Concentration Test (BOMCT) | Baseline, 6 months, 12 months, and 24 months | Change in cognitive function measured using the Blessed Orientation-Memory-Concentration Test (BOMCT) |
| Change in emotional well-being assessed with the "Allgemeine Depressionsskala" short form (ADS-K) | Baseline, 6 months, 12 months, and 24 months | Change in depressive symptoms assessed using the short version of the general depression scale (ADS-K) |
| Change in body composition measured by bioelectrical impedance analysis (BIA) | Baseline, 6 months, 12 months, and 24 months | Change in body composition assessed by bioelectrical impedance analysis using the AKERN BIA 101 device. |
| Change in Venous Excess Ultrasound (VExUS) Score | Baseline, 6 months, 12 months, and 24 months | Change in VExUS Score (bedside ultrasound-based approach with a more comprehensive assessment of venous congestion) measured by duplex ultrasound |
Countries
Germany
Contacts
CONTACTAndrea Schwab
Outcome results
None listed