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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in estimated glomerular filtration rate (eGFR) slope
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TEER-Group
Tricuspid regurgitation group prior to intervention and after intervention
干预措施: Transcatheter edge-to-edge repair (TEER) (Procedure)
结局指标
主要结局
Change in estimated glomerular filtration rate (eGFR) slope
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: Baseline, 6 months, 12 months, and 24 months
Change in functional exercise capacity measured by the 6-minute walk test (6MWT)
次要结局
- Change in kidney venous stasis index (KVSI)(Baseline, 6 months, 12 months, and 24 months)
- Change in body mass index (BMI)(Baseline, 6 months, 12 months, and 24 months)
- Hospitalizations due to heart failure(Baseline, 6 months, 12 months, and 24 months)
- 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 independence in activities of daily living assessed with the Katz Index(Baseline, 6 months, 12 months, and 24 months)
- Change in frailty assessed using the Clinical Frailty Scale (CFS)(Baseline, 6 months, 12 months, and 24 months)
- Change in hand grip strength measured using a Jamar dynamometer(Baseline, 6 months, 12 months, and 24 months)
- Change in functional mobility assessed with the Timed Up and Go Test (TUG)(Baseline, 6 months, 12 months, and 24 months)
- Change in urinary albumin-to-creatinine ratio (UACR)(Baseline, 6 months, 12 months, and 24 months)
- Prevalence of chronic kidney disease (CKD)(Baseline, 6 months, 12 months, and 24 months)
- Incidence of dialysis initiation(Baseline, 6 months, 12 months, and 24 months)
- All-cause mortality(Baseline, 6 months, 12 months, and 24 months)
- Change in cognitive function assessed with 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)(Baseline, 6 months, 12 months, and 24 months)
- Change in body composition measured by bioelectrical impedance analysis (BIA)(Baseline, 6 months, 12 months, and 24 months)
- Change in Venous Excess Ultrasound (VExUS) Score(Baseline, 6 months, 12 months, and 24 months)
研究者
Moritz Schanz
MD, PD Dr.
Robert Bosch Medical Center