Идёт набор NCT07464106

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.

— Наблюдательное Tricuspid Regurgitation Tricuspid Valve Insufficiency Cardio-Renal Syndrome Frailty

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Transcatheter edge-to-edge repair (TEER).
Кому может быть актуально: Состояния в реестре: Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Cardio-Renal Syndrome, Frailty. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

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

Первичные конечные точки

Change in estimated glomerular filtration rate (eGFR) slope [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Incidence of acute kidney injury (AKI) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Physical activity assessed using the activPAL4 micro activity monitor [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in functional exercise capacity assessed with the 6-minute walk test (6MWT) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]

Вторичные конечные точки (12)

Change in kidney venous stasis index (KVSI) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in body mass index (BMI) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Hospitalizations due to heart failure [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in disease-specific quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in independence in activities of daily living assessed with the Katz Index [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in frailty assessed using the Clinical Frailty Scale (CFS) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in hand grip strength measured using a Jamar dynamometer [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in functional mobility assessed with the Timed Up and Go Test (TUG) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Change in urinary albumin-to-creatinine ratio (UACR) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Prevalence of chronic kidney disease (CKD) [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
Incidence of dialysis initiation [Срок оценки: Baseline, 6 months, 12 months, and 24 months]
All-cause mortality [Срок оценки: Baseline, 6 months, 12 months, and 24 months]

Критерии участия

Критерии включения

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