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.
Study Type
OBSERVATIONAL
Enrollment
100
Routine intervention, observational
Robert Bosch Hospital
Stuttgart, Germany
RECRUITINGChange 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 6 months, 12 months, and 24 months
Change in kidney venous stasis index (KVSI)
Change in kidney venous stasis index (KVSI) measured by duplex ultrasound
Time frame: Baseline, 6 months, 12 months, and 24 months
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).
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: Baseline, 6 months, 12 months, and 24 months
Incidence of dialysis initiation
Initiation of chronic renal replacement therapy (hemodialysis or peritoneal dialysis)
Time frame: Baseline, 6 months, 12 months, and 24 months
All-cause mortality
Death from any cause during the study period
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: Baseline, 6 months, 12 months, and 24 months
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