Clinical trial NCT04634266: TRICuspid Intervention in Heart Failure Trial
Official title: TRICuspid Intervention in Heart Failure Trial (TRICI-HF-DZHK24)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure Attributable to Severe Tricuspid Regurgitation
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
Collaborators: name: Heart and Diabetes Center North Rhine-Westphalia
name: University Medical Center Mainz
name: Heart Center Leipzig - University Hospital
name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
name: University of Leipzig
First posted: 2020-11-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, controlled, multicenter, randomized, open label trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All-cause mortality or heart failure hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: All-cause mortality (unadjusted and adjusted for TR severity at baseline)
timeFrame: 12 months
measure: Heart failure hospitalizations (frequency and length; unadjusted and adjusted for TR severity at baseline)
timeFrame: 12 months
measure: Change in Quality of Life as assessed by the MLHFQ from baseline
timeFrame: 12 months
measure: Re-intervention rates for recurrent tricuspid regurgitation
timeFrame: 12 months
measure: Change in NYHA Class from baseline (≥III/IV to ≤I/II)
timeFrame: 12 months
measure: Change in 6 minute walk test distance from baseline
timeFrame: 12 months
measure: Change in echocardiographic parameters (among others: TR grade I-V, RV dimension and function, LV dimension and function, estimation of sPAP)
timeFrame: 12 months
measure: Development of tricuspid stenosis (mean inflow gradient >5mmHg)
timeFrame: 12 months
measure: Change in peripheral edema assessed by the edema scale (grade I-IV) and subject weight (kilograms) from baseline
timeFrame: 12 months
measure: Change of diuretic drugs and heart failure medications from baseline (type and dosage)
timeFrame: 12 months
measure: Change in laboratory markers for cardiac, renal and hepatic function (complete blood count, NT-proBNP, eGFR, serum creatinine, bilirubin, AST, ALT and gGT)
timeFrame: 12 months
Other outcomes:
measure: Safety of transcatheter tricuspid valve intervention
timeFrame: 1 month
Locations:
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann-Klinik
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Dortmund
country: Germany
facility: St.-Johannes-Hospital Dortmund
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen
city: Göttingen
country: Germany
facility: Herzzentrum Göttingen
city: Hamburg
country: Germany
facility: Herzzentrum UKE
city: Hamburg
country: Germany
facility: Katholisches Marienkrankenhaus Hamburg
city: Hamburg
country: Germany
facility: MVZ Prof. Mathey/Schofer
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Köln
country: Germany
facility: Herzzentrum Uniklinik Köln
city: Leipzig
country: Germany
facility: Herzentrum Leipzig
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: München
country: Germany
facility: LMU Klinikum
city: Siegburg
country: Germany
facility: Herzzentrum Siegburg
Study officials:
References: