Treatment for severe tricuspid regurgitation in heart failure patients

TRICuspid Intervention in Heart Failure Trial (TRICI-HF-DZHK24)

This study is testing a new less invasive heart treatment for people with heart failure caused by severe tricuspid regurgitation to see if it helps them feel better compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 360 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: LMU Klinikum (Academic / other)
• Locations: 23 sites (Bad Krozingen and 22 other locations)
• Trial ID: NCT04634266 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of transcatheter tricuspid valve treatment (TTVT) for patients suffering from heart failure due to severe tricuspid regurgitation (TR). The study aims to enroll symptomatic patients who are at intermediate or greater risk for traditional surgical interventions. By utilizing innovative percutaneous techniques such as transcatheter annuloplasty and edge-to-edge repair, the trial seeks to provide a less invasive alternative to surgery. The goal is to assess the functional outcomes of these treatments compared to standard care.

Who should consider this trial

Good fit: Ideal candidates include symptomatic adults aged 18 and older with severe TR who are at high risk for surgery and have been on stable medical therapy.

Not a fit: Patients with mild TR or those who are not symptomatic may not benefit from this intervention.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life and survival rates for patients with severe TR who are currently deemed inoperable.

How similar studies have performed: While several non-randomized studies have shown promising results for TTVT, this trial is among the first to evaluate its efficacy in a randomized controlled setting.

Eligibility criteria

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. Patients with reduced left ventricular ejection fraction (HFrEF) will likely constitute a minority among eligible patients with isolated severe tricuspid regurgitation (9,13). However, HFrEF patients enrolled into the trial need to be on stable guideline-directed medical therapy for at least 4 weeks..
* Subject is at intermediate or greater estimated risk of mortality with tricuspid valve surgery based on judgment of the local heart team
* 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 valve procedures or tricuspid valve leaflet anatomy that would interfere with appropriate TTVT (e.g. calcification, Ebstein anomaly, coaptation defect \> 8mm for planned leaflet- and annuloplasty-based therapy)
* Chronic renal failure requiring dialysis
* Tricuspid valve anatomy not evaluable by TTE and TEE
* Myocardial infarction or cerebrovascular accident within prior 90 days
* Life expectancy of less than 12 months

Where this trial is running

Bad Krozingen and 22 other locations

• Herzzentrum Bad Krozingen — Bad Krozingen, Germany (Not_yet_recruiting)
• Herz- und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen, Germany (Not_yet_recruiting)
• Schüchtermann-Klinik — Bad Rothenfelde, Germany (Not_yet_recruiting)
• Charité Universitätsmedizin Berlin — Berlin, Germany (Not_yet_recruiting)
• Deutsches Herzzentrum Berlin — Berlin, Germany (Not_yet_recruiting)
• Universitätsklinikum Bonn — Bonn, Germany (Not_yet_recruiting)
• St.-Johannes-Hospital Dortmund — Dortmund, Germany (Not_yet_recruiting)
• Helios Klinikum Erfurt — Erfurt, Germany (Not_yet_recruiting)
• Universitätsklinikum Essen — Essen, Germany (Not_yet_recruiting)
• Universitätsklinikum Frankfurt — Frankfurt, Germany (Not_yet_recruiting)
• Universitätsklinikum Freiburg — Freiburg, Germany (Not_yet_recruiting)
• Universitätsklinikum Giessen — Giessen, Germany (Not_yet_recruiting)
• Herzzentrum Göttingen — Göttingen, Germany (Not_yet_recruiting)
• Herzzentrum UKE — Hamburg, Germany (Not_yet_recruiting)
• Katholisches Marienkrankenhaus Hamburg — Hamburg, Germany (Recruiting)
• MVZ Prof. Mathey/Schofer — Hamburg, Germany (Recruiting)
• Universitätsklinikum Jena — Jena, Germany (Not_yet_recruiting)
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany (Recruiting)
• Herzzentrum Uniklinik Köln — Köln, Germany (Not_yet_recruiting)
• Herzentrum Leipzig — Leipzig, Germany (Not_yet_recruiting)
• Universitätsmedizin Mainz — Mainz, Germany (Not_yet_recruiting)
• LMU Klinikum — München, Germany (Recruiting)
• Herzzentrum Siegburg — Siegburg, Germany (Not_yet_recruiting)

Study contacts

• Study coordinator: Joerg Hausleiter, MD

Conditions Heart Failure Attributable to Severe Tricuspid Regurgitation