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. (TriRenGe)

March 9, 2026 updated by: Moritz Schanz, Robert Bosch Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population includes adult patients with severe symptomatic tricuspid valve insufficiency who are referred for TriClip/TricValve screening and are aged 18 years or older. Participants must be able to provide informed consent and have the capacity to walk short distances with the aid of mobility devices.

Exclusion criteria include dialysis-dependent or terminal kidney disease, inability to comply with study-related assessments (e.g., due to dementia or cognitive decline), severe anemia (Hb <7 g/dl), and the need for a tricuspid valve intervention with palliative intent, with a likely imminent death. Additionally, patients who are unable or unwilling to provide informed consent will be excluded from the study.

This population represents individuals who are eligible for the intervention, while the exclusions ensure that participants can meaningfully engage in the study assessments and outcomes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TEER-Group
Tricuspid regurgitation group prior to intervention and after intervention
Procedure: Transcatheter edge-to-edge repair (TEER)
Routine intervention, observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 6 months, 12 months, and 24 months
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.
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
Physical activity measured over a 7-day monitoring period using the activPAL4 micro activity monitor (PAL Technologies, Glasgow, UK)
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
Change in functional exercise capacity measured by the 6-minute walk test (6MWT)
Baseline, 6 months, 12 months, and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 6 months, 12 months, and 24 months
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).
Baseline, 6 months, 12 months, and 24 months
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.
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 disease-specific quality of life measured using the Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)
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 independence in activities of daily living measured using the Katz Index.
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 frailty status measured using the Clinical Frailty Scale (CFS)
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 muscle strength assessed by hand grip strength using a manual dynamometer (Jamar).
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 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.
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
Change in albuminuria measured as urinary albumin-to-creatinine ratio (UACR) in spot urine samples (mg/gCreatinine)
Baseline, 6 months, 12 months, and 24 months
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.
Baseline, 6 months, 12 months, and 24 months
Incidence of dialysis initiation
Time Frame: Baseline, 6 months, 12 months, and 24 months
Initiation of chronic renal replacement therapy (hemodialysis or peritoneal dialysis)
Baseline, 6 months, 12 months, and 24 months
All-cause mortality
Time Frame: Baseline, 6 months, 12 months, and 24 months
Death from any cause during the study period
Baseline, 6 months, 12 months, and 24 months
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)
Baseline, 6 months, 12 months, and 24 months
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)
Baseline, 6 months, 12 months, and 24 months
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.
Baseline, 6 months, 12 months, and 24 months
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
Baseline, 6 months, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Bosch Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 21, 2025

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S 848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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