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TRICuspid Intervention in Heart Failure Trial (TRICI-HF)

Primary Purpose

Heart Failure Attributable to Severe Tricuspid Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcatheter tricuspid valve treatment (TTVT)
Sponsored by
LMU Klinikum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure Attributable to Severe Tricuspid Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Herzzentrum Bad Krozingen
  • Herz- und Diabeteszentrum Nordrhein-Westfalen
  • Schüchtermann-Klinik
  • Charité Universitätsmedizin Berlin
  • Deutsches Herzzentrum Berlin
  • Universitätsklinikum Bonn
  • St.-Johannes-Hospital Dortmund
  • Helios Klinikum Erfurt
  • Universitätsklinikum Essen
  • Universitätsklinikum Frankfurt
  • Universitätsklinikum Freiburg
  • Universitätsklinikum Giessen
  • Herzzentrum Göttingen
  • Herzzentrum UKE
  • Katholisches Marienkrankenhaus HamburgRecruiting
  • MVZ Prof. Mathey/SchoferRecruiting
  • Universitätsklinikum Jena
  • Universitätsklinikum Schleswig-HolsteinRecruiting
  • Herzzentrum Uniklinik Köln
  • Herzentrum Leipzig
  • Universitätsmedizin Mainz
  • LMU KlinikumRecruiting
  • Herzzentrum Siegburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental intervention

Control intervention

Arm Description

Transcatheter tricuspid valve treatment (TTVT) plus optimal medical therapy (OMT)

OMT for severe tricuspid regurgitation in right-sided heart failure

Outcomes

Primary Outcome Measures

All-cause mortality or heart failure hospitalization
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

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

Full Information

First Posted
November 17, 2020
Last Updated
August 19, 2022
Sponsor
LMU Klinikum
Collaborators
Heart and Diabetes Center North Rhine-Westphalia, University Medical Center Mainz, Heart Center Leipzig - University Hospital, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University of Leipzig
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1. Study Identification

Unique Protocol Identification Number
NCT04634266
Brief Title
TRICuspid Intervention in Heart Failure Trial
Acronym
TRICI-HF
Official Title
TRICuspid Intervention in Heart Failure Trial (TRICI-HF-DZHK24)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2022 (Actual)
Primary Completion Date
March 1, 2026 (Anticipated)
Study Completion Date
March 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
LMU Klinikum
Collaborators
Heart and Diabetes Center North Rhine-Westphalia, University Medical Center Mainz, Heart Center Leipzig - University Hospital, Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK), University of Leipzig

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure Attributable to Severe Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Prospective, controlled, multicenter, randomized, open label trial
Masking
Investigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental intervention
Arm Type
Experimental
Arm Description
Transcatheter tricuspid valve treatment (TTVT) plus optimal medical therapy (OMT)
Arm Title
Control intervention
Arm Type
No Intervention
Arm Description
OMT for severe tricuspid regurgitation in right-sided heart failure
Intervention Type
Device
Intervention Name(s)
Transcatheter tricuspid valve treatment (TTVT)
Intervention Description
Percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT): These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL).
Primary Outcome Measure Information:
Title
All-cause mortality or heart failure hospitalization
Description
Composite of time to all-cause mortality or heart failure hospitalization - whichever occurs first - at a minimum follow-up of 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
All-cause mortality (unadjusted and adjusted for TR severity at baseline)
Time Frame
12 months
Title
Heart failure hospitalizations (frequency and length; unadjusted and adjusted for TR severity at baseline)
Time Frame
12 months
Title
Change in Quality of Life as assessed by the MLHFQ from baseline
Time Frame
12 months
Title
Re-intervention rates for recurrent tricuspid regurgitation
Time Frame
12 months
Title
Change in NYHA Class from baseline (≥III/IV to ≤I/II)
Time Frame
12 months
Title
Change in 6 minute walk test distance from baseline
Time Frame
12 months
Title
Change in echocardiographic parameters (among others: TR grade I-V, RV dimension and function, LV dimension and function, estimation of sPAP)
Time Frame
12 months
Title
Development of tricuspid stenosis (mean inflow gradient >5mmHg)
Time Frame
12 months
Title
Change in peripheral edema assessed by the edema scale (grade I-IV) and subject weight (kilograms) from baseline
Time Frame
12 months
Title
Change of diuretic drugs and heart failure medications from baseline (type and dosage)
Time Frame
12 months
Title
Change in laboratory markers for cardiac, renal and hepatic function (complete blood count, NT-proBNP, eGFR, serum creatinine, bilirubin, AST, ALT and gGT)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Safety of transcatheter tricuspid valve intervention
Description
Major adverse events that are related to the intervention and are relevant for patients undergoing TTVT: Mortality, life threatening bleeding (defined as BARC bleeding type 3 and 5), major vascular or cardiac structural complications requiring intervention, or mechanical circulatory support.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joerg Hausleiter, MD
Phone
+4989440072361
Email
joerg.hausleiter@med.uni-muenchen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Stocker, MD
Phone
+49894400712625
Email
thomas.stocker@med.uni-muenchen.de
Facility Information:
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Comberg
Facility Name
Herz- und Diabeteszentrum Nordrhein-Westfalen
City
Bad Oeynhausen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volker Rudolph
Facility Name
Schüchtermann-Klinik
City
Bad Rothenfelde
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Kowalski
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulf Landmesser
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Volkmar Falk
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Nickenig
Facility Name
St.-Johannes-Hospital Dortmund
City
Dortmund
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helge Möllmann
Facility Name
Helios Klinikum Erfurt
City
Erfurt
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Lauten
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tienush Rassaf
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Zeiher
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Bode
Facility Name
Universitätsklinikum Giessen
City
Giessen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Nef
Facility Name
Herzzentrum Göttingen
City
Göttingen
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudius Jacobshagen
Facility Name
Herzzentrum UKE
City
Hamburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Schofer, MD
Email
n.schofer@uke.de
Facility Name
Katholisches Marienkrankenhaus Hamburg
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elke Lubos, MD
Email
e.lubos@marienkrankenhaus.org
Facility Name
MVZ Prof. Mathey/Schofer
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joachim Schofer
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Schulze
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Derk Frank
Facility Name
Herzzentrum Uniklinik Köln
City
Köln
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Baldus
Facility Name
Herzentrum Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipp Lurz
Facility Name
Universitätsmedizin Mainz
City
Mainz
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan von Bardeleben
Facility Name
LMU Klinikum
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg Hausleiter, MD
First Name & Middle Initial & Last Name & Degree
Joerg Hausleiter, MD
First Name & Middle Initial & Last Name & Degree
Thomas Stocker, MD
First Name & Middle Initial & Last Name & Degree
Daniel Braun, MD
First Name & Middle Initial & Last Name & Degree
Steffen Massberg
Facility Name
Herzzentrum Siegburg
City
Siegburg
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Boekstegers

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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TRICuspid Intervention in Heart Failure Trial

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