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.

NCT07464106 | Recruiting

• 1 other identifier: S 848
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Cardio-Renal Syndrome; Frailty

Outcome Measures

Primary Outcomes (4)

• Change in estimated glomerular filtration rate (eGFR) slope

  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)

  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

  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)

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

  Baseline, 6 months, 12 months, and 24 months

Secondary Outcomes (16)

• 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

Study Arms (1)

TEER-Group

Tricuspid regurgitation group prior to intervention and after intervention

Procedure: Transcatheter edge-to-edge repair (TEER)

Interventions

Transcatheter edge-to-edge repair (TEER) PROCEDURE

Routine intervention, observational

TEER-Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Bosch Medical Center: lead

Study Sites (1)

Robert Bosch Hospital

Stuttgart, Germany

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Cardio-Renal Syndrome; Frailty

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Schwab

CONTACT

071181010; Sekretariat-Nephrologie@rbk.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PD Dr.

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: March 11, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2025-09

Locations

DE (1)