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Recruiting 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.

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter edge-to-edge repair (TEER).
Who it may be relevant to
Registry conditions: Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Cardio-Renal Syndrome, Frailty. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Change in estimated glomerular filtration rate (eGFR) slope [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Incidence of acute kidney injury (AKI) [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Physical activity assessed using the activPAL4 micro activity monitor [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Change in functional exercise capacity assessed with the 6-minute walk test (6MWT) [Time frame: Baseline, 6 months, 12 months, and 24 months]
Secondary outcome measures (12)
  • Change in kidney venous stasis index (KVSI) [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Change in body mass index (BMI) [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Hospitalizations due to heart failure [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) [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Change in independence in activities of daily living assessed with the Katz Index [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Change in frailty assessed 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 [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Change in functional mobility assessed with the Timed Up and Go Test (TUG) [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Change in urinary albumin-to-creatinine ratio (UACR) [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Prevalence of chronic kidney disease (CKD) [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • Incidence of dialysis initiation [Time frame: Baseline, 6 months, 12 months, and 24 months]
  • All-cause mortality [Time frame: Baseline, 6 months, 12 months, and 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Robert Bosch Hospital — Stuttgart

Identifiers

NCT: NCT07464106 · S 848

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗