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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The following inclusion criteria were defined to assure generalizability of the population to be studied:
* Subject is symptomatic due to severe TR despite being on stable OMT for at least 30 days based on judgment of the local heart team.
* Subject is at intermediate or greater estimated risk of morbidity and mortality, defined as a) hospitalization for heart failure during the previous 12 months, or b) cardio-renal syndromea or c) cardio-hepatic syndrome
* New York Heart Association (NYHA) Functional Class II, III or IVa
* Femoral vein access and valve anatomy are determined to be feasible for interventional treatment (including sufficient quality of TTE and TEE imaging)
* Age ≥ 18 years at time of consent
* Subject must provide written informed consent prior to any trial related procedure
The following exclusion criteria were selected to define a representative study cohort:
* Presence of severe aortic, mitral or pulmonary valve disease OR surgical/interventional treatment at the aortic, mitral or pulmonary valves prior 60 days
* Right heart catheterization (mandatory) with systolic pulmonary artery pressure \> 70 mmHg or substantial pre-capillary pulmonary hypertension (defined as mean pulmonary artery pressure (mPAP) \>30 mmHg plus transpulmonary gradient (TPG) \>17 mmHg or pulmonary vascular resistance (PVR) \>5 wood units)
* Tricuspid valve stenosis (tricuspid mean gradient \> 5 mmHg)
* Pacemaker or ICD leads that would prevent appropriate TTVT
* Prior tricuspid val…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of mortality, heart failure hospitalization and quality of life improvement
Timeframe: 12 months
2
All-cause mortality or heart failure hospitalization