TRICuspid Intervention in Heart Failure Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter tricuspid valve treatment (TTVT): Percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT): These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Composite of mortality, heart failure hospitalization and quality of life improvement — 12 months
  Hierarchical composite of all-cause mortality, number of HFH, and lack of QoL improvement (KCCQ improvement of at least 15 points between baseline and follow-up) at 12 months
• All-cause mortality or heart failure hospitalization — minimum follow-up of 12 months
  Composite of time to all-cause mortality or heart failure hospitalization - whichever occurs first - at a minimum follow-up of 12 months

Trial sites (28)

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