TRICuspid Intervention in Heart Failure Trial

Aims: Tricuspid regurgitation (TR) is a detrimental disease frequently diagnosed in patients with right-sided heart failure (HF). While transcatheter tricuspid valve interventions (TTVI) effectively reduce TR and improve quality of life (QoL) in earlier stages of the disease, their effect on reducing HF hospitalizations (HFH) and improving survival remains unclear. Methods: TRIC-I-HF-DZHK24 is an investigator-initiated, prospective, randomized, open-label, multi-center strategy trial. Approximately 360 patients with severe TR and manifest right-sided HF will be enrolled. In contrast to previous trials, subjects with increased risk for HFH will be selected as facilitated by specific inclusion criteria: HFH in the previous year, or presence of cardio-renal syndrome, or evidence for cardio-hepatic syndrome. Subjects will be randomized 2:1 to TTVI and optimal medical therapy (OMT) or continuation of OMT alone. All CE-marked transcatheter repair devices including tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid annuloplasty can be used for TTVI. The participating 29 study sites are highly experienced in T-TEER. The primary outcome will be assessed at one year. First, a composite of all-cause mortality, HFH, and QoL improvement will be tested hierarchically. If positive, the combination of hard clinical endpoints including all-cause mortality and HFH will be tested. Patients will be followed for a total of 3 years. The safety outcome comprises complications of TTVI, life threatening bleeding and death. Conclusions: The TRIC-I-HF-DZHK24 trial will define the role of TTVI in patients with severe TR and right-sided HF.

NCT Number	NCT04634266
Lead Sponsor	LMU Klinikum Collaborators: Heart and Diabetes Center North Rhine-Westphalia, University Medical Center Mainz, Heart Center Leipzig - University Hospital, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Conditions	Heart Failure Attributable to Severe Tricuspid Regurgitation
Enrollment	360 participants
Start Date	2022-03-25
Primary Completion	2026-07-01 (estimated)
Study Completion	2028-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-22