Rationale and Design of the TRIC-I-HF-DZHK24 (TRICuspid Intervention in Heart Failure) Trial
Year: 2025
Type: article
Study design: Study Protocol
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.
DOI: 10.1002/ejhf.3795
Authors: Thomas J. Stocker, Tobias Geisler, Wolfgang Rottbauer, Edith Lubos, Christian Frerker, Niklas Schofer, Johanne Frank, Ralph Stephan von Bardeleben, Tobias Kister, Rico Osteresch, Alexander Lauten, Tienush Rassaf, Jürgen Rothe, David M. Leistner, Lukas Stolz, Victoria Kehl, Maria Grzeschniok, Andreas Hagendorff, Volker Rudolph, Stephan Baldus, Philipp Lurz, Steffen Massberg, Jörg Hausleiter, for the TRIC-I-HF-DZHK24 Investigators
Institutions: LMU Klinikum, German Centre for Cardiovascular Research, Ludwig-Maximilians-Universität München, University of Tübingen, Universität Ulm, Marienkrankenhaus Hamburg, University of Lübeck, Universität Hamburg, University Medical Center Hamburg-Eppendorf, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Leipzig Heart Institute, University Hospital Leipzig, Leipzig University, Klinikum Links der Weser, Helios Klinikum Erfurt, Essen University Hospital, West German Heart and Vascular Center Essen, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Goethe University Frankfurt, Technical University of Munich, Heart and Diabetes Center North Rhine-Westphalia, University of Cologne
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,300
OpenAlex ID: W4413099737