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.

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter edge-to-edge repair (TEER): Routine intervention, observational

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (1)

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