TRICuspid Intervention in Heart Failure Trial

Not Applicable

Recruiting

• Conditions: Heart Failure Attributable to Severe Tricuspid Regurgitation
• Interventions: Device: Transcatheter tricuspid valve treatment (TTVT)

• Registration Number: NCT04634266
• Lead Sponsor: LMU Klinikum

Brief Summary

Functional tricuspid regurgitation (TR) is a serious and progressive disease. Guidelines recommend surgical valve repair of severe TR in symptomatic patients. Despite its association with excess mortality and morbidity, TR has been relatively neglected and is severely undertreated. In particular this is because isolated tricuspid surgery remains associated with high mortality rates, and thus, patients with severe TR are often deemed inoperable due to severe co-morbidities and frailty. In recent years, percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT) have emerged as alternatives to surgery. These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL). Several non-randomized studies suggested improved functional outcomes after TTVT, however, to data there is no evidence from randomized controlled trials addressing the actual efficacy of TTVT. The TRICuspid Intervention in Heart Failure trial (TRICI-HF trial) will assess the concept that TTVT will translate into a reduced morbidity and mortality. Patients will be randomly assigned in a 2:1 fashion to TTVT plus OMT (Experimental group) or OMT alone (Control group). TRICI-HF is an industry-independent, investigator-initiated strategy study and investigators may choose any suitable CE-marked percutaneous system "on-label" for TTVT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-18
• Study Start: 2022-02-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-23
• Primary Completion: 2026-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental intervention	Transcatheter tricuspid valve treatment (TTVT)	Transcatheter tricuspid valve treatment (TTVT) plus optimal medical therapy (OMT)

Primary Outcome Measures

Name	Time	Method
All-cause mortality or heart failure hospitalization	12 months	Composite of time to all-cause mortality or heart failure hospitalization - whichever occurs first - at a minimum follow-up of 12 months

Secondary Outcome Measures

Name	Time	Method
All-cause mortality (unadjusted and adjusted for TR severity at baseline)	12 months
Change in Quality of Life as assessed by the MLHFQ from baseline	12 months
Development of tricuspid stenosis (mean inflow gradient >5mmHg)	12 months
Change of diuretic drugs and heart failure medications from baseline (type and dosage)	12 months
Re-intervention rates for recurrent tricuspid regurgitation	12 months
Change in 6 minute walk test distance from baseline	12 months
Heart failure hospitalizations (frequency and length; unadjusted and adjusted for TR severity at baseline)	12 months
Change in NYHA Class from baseline (≥III/IV to ≤I/II)	12 months
Change in laboratory markers for cardiac, renal and hepatic function (complete blood count, NT-proBNP, eGFR, serum creatinine, bilirubin, AST, ALT and gGT)	12 months
Change in echocardiographic parameters (among others: TR grade I-V, RV dimension and function, LV dimension and function, estimation of sPAP)	12 months
Change in peripheral edema assessed by the edema scale (grade I-IV) and subject weight (kilograms) from baseline	12 months

Trial Locations

Locations (23)

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Herzzentrum Siegburg; 🇩🇪 Siegburg, Germany

Helios Klinikum Erfurt; 🇩🇪 Erfurt, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Herzzentrum Göttingen; 🇩🇪 Göttingen, Germany

Herzzentrum Uniklinik Köln; 🇩🇪 Köln, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Herzentrum Leipzig; 🇩🇪 Leipzig, Germany

Universitätsklinikum Giessen; 🇩🇪 Giessen, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany

Herzzentrum UKE; 🇩🇪 Hamburg, Germany

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Herz- und Diabeteszentrum Nordrhein-Westfalen; 🇩🇪 Bad Oeynhausen, Germany

Schüchtermann-Klinik; 🇩🇪 Bad Rothenfelde, Germany

St.-Johannes-Hospital Dortmund; 🇩🇪 Dortmund, Germany

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Katholisches Marienkrankenhaus Hamburg; 🇩🇪 Hamburg, Germany

MVZ Prof. Mathey/Schofer; 🇩🇪 Hamburg, Germany

Universitätsklinikum Jena; 🇩🇪 Jena, Germany

Universitätsmedizin Mainz; 🇩🇪 Mainz, Germany

LMU Klinikum; 🇩🇪 München, Germany