Rationale and design of the TRIC-I-HF-DZHK24 (TRICuspid Intervention in Heart Failure) trial.

Abstract

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 (NCT04634266) is an investigator-initiated, prospective, randomized, open-label, multicentre 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 and treated a mean of 176 patients in 4.5 years with T-TEER before study activation. The primary outcome will be assessed at 1 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.