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NCT Number: 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.

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.

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Key information

Conditions

Tricuspid Regurgitation Cardio-Renal Syndrome Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Heart Diseases Heart Failure Heart Valve Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Tricuspid Valve Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert Bosch Hospital

Stuttgart, Germany

Location status: Recruiting

Location contact

Andrea Schwab

CONTACT

[email protected]

0711/8101-0

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcatheter edge-to-edge repair (TEER)

Procedure

Routine intervention, observational

Primary outcomes

  1. Change in estimated glomerular filtration rate (eGFR) slope

    Time frame: 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)

  2. Incidence of acute kidney injury (AKI)

    Time frame: 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.

  3. Physical activity assessed using the activPAL4 micro activity monitor

    Time frame: 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)

  4. Change in functional exercise capacity assessed with the 6-minute walk test (6MWT)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in functional exercise capacity measured by the 6-minute walk test (6MWT)

Secondary outcomes

  1. Change in kidney venous stasis index (KVSI)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in kidney venous stasis index (KVSI) measured by duplex ultrasound

  2. Change in body mass index (BMI)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in body mass index calculated as body weight in kilograms divided by height in meters squared (kg/m²).

  3. Hospitalizations due to heart failure

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Number of hospitalizations due to worsening heart failure during the study period.

  4. 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 disease-specific quality of life measured using the Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)

  5. 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 independence in activities of daily living measured using the Katz Index.

  6. Change in frailty assessed using the Clinical Frailty Scale (CFS)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in frailty status measured using the Clinical Frailty Scale (CFS)

  7. Change in hand grip strength measured using a Jamar dynamometer

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in muscle strength assessed by hand grip strength using a manual dynamometer (Jamar).

  8. 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 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.

  9. Change in urinary albumin-to-creatinine ratio (UACR)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in albuminuria measured as urinary albumin-to-creatinine ratio (UACR) in spot urine samples (mg/gCreatinine)

  10. Prevalence of chronic kidney disease (CKD)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Presence of chronic kidney disease defined according to KDIGO criteria based on estimated glomerular filtration rate (eGFR) and markers of kidney damage.

  11. Incidence of dialysis initiation

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Initiation of chronic renal replacement therapy (hemodialysis or peritoneal dialysis)

  12. All-cause mortality

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Death from any cause during the study period

  13. Change in cognitive function assessed with the Blessed Orientation-Memory-Concentration Test (BOMCT)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in cognitive function measured using the Blessed Orientation-Memory-Concentration Test (BOMCT)

  14. Change in emotional well-being assessed with the "Allgemeine Depressionsskala" short form (ADS-K)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in depressive symptoms assessed using the short version of the general depression scale (ADS-K)

  15. Change in body composition measured by bioelectrical impedance analysis (BIA)

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in body composition assessed by bioelectrical impedance analysis using the AKERN BIA 101 device.

  16. Change in Venous Excess Ultrasound (VExUS) Score

    Time frame: Baseline, 6 months, 12 months, and 24 months

    Change in VExUS Score (bedside ultrasound-based approach with a more comprehensive assessment of venous congestion) measured by duplex ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Schwab

CONTACT

[email protected]

071181010

Sponsors and collaborators

Lead sponsor

Robert Bosch Medical Center

Other

Registry information

Acronym: TriRenGe

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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