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Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure (TRUST CRT)

Primary Purpose

Congestive Heart Failure, Heart Disease

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads
Triple-site cardiac resynchronization
Sponsored by
Silesian Centre for Heart Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Heart failure, Dyssynchrony, Cardiac resynchronization, Triple-site pacing

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 or more,
  • Congestive heart failure (HF) in NYHA class III-IV within last 90 days despite optimal medical treatment,
  • Left ventricular ejection fraction (EF) <=35% measured with echocardiography,
  • Sinus rhythm >90% of the time in 24-h Holter monitoring 1-3 days prior to randomization,
  • Inter- or intraventricular mechanical dyssynchrony ≥40ms measured with pulse Doppler and tissue Doppler echocardiography,
  • Optimal pharmacotherapy during the last 90 days,
  • Signed informed, written consent.

Exclusion Criteria:

  • Pregnancy or breastfeeding,
  • Unstable HF requiring hospitalization with intravenous inotropic drugs within last 90 days,
  • Myocardial infarction, percutaneous/surgical revascularization or any cardiosurgical procedure within 90 days prior to randomization,
  • Stroke within last 90 days,
  • History of chronic or persistent atrial fibrillation, flutter, tachycardia,
  • Acute myocarditis,
  • Implanted previously pacemaker, ICD or CRT-device,
  • Participation in a concurrent trial that could confuse the results of this study,
  • Mechanical right heart valve,
  • Prior heart transplant,
  • Valvular disease that is indication for valve surgery,
  • Coronary heart disease if percutaneous or surgical revascularization is indicated and possible,
  • Any state, apart from HF, that limits the estimated survival time to <1 year,
  • Unwillingness or inability to understand the nature of the study, to participate or to give written informed consent.

Sites / Locations

  • First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triple-site group

Standard resynchronization group

Arm Description

Triple-site resynchronization group

Standard (double-site) resynchronization group

Outcomes

Primary Outcome Measures

Combined end-point of alive status, freedom from hospitalization for HF or heart transplantation, relative ≥10% increase in LV ejection fraction, ≥10% in VO2max and ≥10% in 6MWD.

Secondary Outcome Measures

The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death).

Full Information

First Posted
December 22, 2008
Last Updated
April 12, 2016
Sponsor
Silesian Centre for Heart Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT00814840
Brief Title
Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure
Acronym
TRUST CRT
Official Title
Triple-Site Versus Standard Cardiac Resynchronization Therapy (TRUST CRT) Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Silesian Centre for Heart Diseases

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the efficiency of permanent biventricular pacing using three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in cardiac capacity and patients' functional status in subjects with congestive heart failure and a physiologic (sinus) rhythm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Heart Disease
Keywords
Heart failure, Dyssynchrony, Cardiac resynchronization, Triple-site pacing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triple-site group
Arm Type
Active Comparator
Arm Description
Triple-site resynchronization group
Arm Title
Standard resynchronization group
Arm Type
Active Comparator
Arm Description
Standard (double-site) resynchronization group
Intervention Type
Device
Intervention Name(s)
Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads
Intervention Description
Cardiac resynchronization with two intraventricular leads: one in the right ventricle and one in the left ventricle (via the coronary sinus)
Intervention Type
Device
Intervention Name(s)
Triple-site cardiac resynchronization
Intervention Description
Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with three intraventricular leads: one in the right ventricle and two in the left ventricle (via the coronary sinus). Two left ventricular leads connected with Y-connector (Lead Adaptor 2827, Medtronic, Minneapolis, MN, USA)
Primary Outcome Measure Information:
Title
Combined end-point of alive status, freedom from hospitalization for HF or heart transplantation, relative ≥10% increase in LV ejection fraction, ≥10% in VO2max and ≥10% in 6MWD.
Time Frame
six months
Secondary Outcome Measure Information:
Title
The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death).
Time Frame
five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or more, Congestive heart failure (HF) in NYHA class III-IV within last 90 days despite optimal medical treatment, Left ventricular ejection fraction (EF) <=35% measured with echocardiography, Sinus rhythm >90% of the time in 24-h Holter monitoring 1-3 days prior to randomization, Inter- or intraventricular mechanical dyssynchrony ≥40ms measured with pulse Doppler and tissue Doppler echocardiography, Optimal pharmacotherapy during the last 90 days, Signed informed, written consent. Exclusion Criteria: Pregnancy or breastfeeding, Unstable HF requiring hospitalization with intravenous inotropic drugs within last 90 days, Myocardial infarction, percutaneous/surgical revascularization or any cardiosurgical procedure within 90 days prior to randomization, Stroke within last 90 days, History of chronic or persistent atrial fibrillation, flutter, tachycardia, Acute myocarditis, Implanted previously pacemaker, ICD or CRT-device, Participation in a concurrent trial that could confuse the results of this study, Mechanical right heart valve, Prior heart transplant, Valvular disease that is indication for valve surgery, Coronary heart disease if percutaneous or surgical revascularization is indicated and possible, Any state, apart from HF, that limits the estimated survival time to <1 year, Unwillingness or inability to understand the nature of the study, to participate or to give written informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radosław Lenarczyk, M.D.
Organizational Affiliation
First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zbigniew Kalarus, M.D.
Organizational Affiliation
First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
Official's Role
Study Chair
Facility Information:
Facility Name
First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18242737
Citation
Lenarczyk R, Kowalski O, Kukulski T, Pruszkowska-Skrzep P, Sokal A, Szulik M, Zielinska T, Kowalczyk J, Pluta S, Sredniawa B, Musialik-Lydka A, Kalarus Z. Mid-term outcomes of triple-site vs. conventional cardiac resynchronization therapy: a preliminary study. Int J Cardiol. 2009 Mar 20;133(1):87-94. doi: 10.1016/j.ijcard.2007.12.009. Epub 2008 Feb 19.
Results Reference
background
PubMed Identifier
17631515
Citation
Lenarczyk R, Kowalski O, Kukulski T, Szulik M, Pruszkowska-Skrzep P, Zielinska T, Kowalczyk J, Pluta S, Duszanska A, Sredniawa B, Musialik-Lydka A, Kalarus Z. Triple-site biventricular pacing in patients undergoing cardiac resynchronization therapy: a feasibility study. Europace. 2007 Sep;9(9):762-7. doi: 10.1093/europace/eum140. Epub 2007 Jul 13.
Results Reference
background
PubMed Identifier
18402900
Citation
Leclercq C, Gadler F, Kranig W, Ellery S, Gras D, Lazarus A, Clementy J, Boulogne E, Daubert JC; TRIP-HF (Triple Resynchronization In Paced Heart Failure Patients) Study Group. A randomized comparison of triple-site versus dual-site ventricular stimulation in patients with congestive heart failure. J Am Coll Cardiol. 2008 Apr 15;51(15):1455-62. doi: 10.1016/j.jacc.2007.11.074.
Results Reference
background
PubMed Identifier
19635069
Citation
Lenarczyk R, Kowalski O, Sredniawa B, Pruszkowska-Skrzep P, Pluta S, Sokal A, Kukulski T, Stabryla-Deska J, Wozniak A, Kowalczyk J, Zielinska T, Mazurek M, Streb W, Zembala M, Kalarus Z. Triple-site versus standard cardiac resynchronization therapy study (TRUST CRT): clinical rationale, design, and implementation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):658-62. doi: 10.1111/j.1540-8167.2008.01394.x.
Results Reference
background
PubMed Identifier
22651239
Citation
Lenarczyk R, Kowalski O, Sredniawa B, Pruszkowska-Skrzep P, Mazurek M, Jedrzejczyk-Patej E, Wozniak A, Pluta S, Glowacki J, Kalarus Z. Implantation feasibility, procedure-related adverse events and lead performance during 1-year follow-up in patients undergoing triple-site cardiac resynchronization therapy: a substudy of TRUST CRT randomized trial. J Cardiovasc Electrophysiol. 2012 Nov;23(11):1228-36. doi: 10.1111/j.1540-8167.2012.02375.x. Epub 2012 May 31.
Results Reference
result
PubMed Identifier
25319879
Citation
Lenarczyk R, Jedrzejczyk-Patej E, Mazurek M, Szulik M, Kowalski O, Pruszkowska P, Sokal A, Sredniawa B, Boidol J, Kowalczyk J, Podolecki T, Mencel G, Kalarus Z. Quality of life in cardiac resynchronization recipients: association with response and impact on outcome. Pacing Clin Electrophysiol. 2015 Jan;38(1):8-17. doi: 10.1111/pace.12523. Epub 2014 Oct 15.
Results Reference
derived
PubMed Identifier
24626998
Citation
Kowalczyk J, Lenarczyk R, Kowalski O, Podolecki T, Francuz P, Pruszkowska-Skrzep P, Szulik M, Mazurek M, Jedrzejczyk-Patej E, Sredniawa B, Kalarus Z; Triple-Site Versus Standard Cardiac Resynchronization Trial (TRUST CRT) Investigators. Contrast-induced acute kidney injury in patients undergoing cardiac resynchronization therapy-incidence and prognostic importance. Sub-analysis of data from randomized TRUST CRT trial. J Interv Card Electrophysiol. 2014 Jun;40(1):1-8. doi: 10.1007/s10840-014-9887-x. Epub 2014 Mar 14.
Results Reference
derived
PubMed Identifier
23487543
Citation
Boidol J, Sredniawa B, Kowalski O, Szulik M, Mazurek M, Sokal A, Pruszkowska-Skrzep P, Kukulski T, Kalarus Z, Lenarczyk R; Triple-Site Versus Standard Cardiac Resynchronisation Trial (TRUST CRT) Investigators. Many response criteria are poor predictors of outcomes after cardiac resynchronization therapy: validation using data from the randomized trial. Europace. 2013 Jun;15(6):835-44. doi: 10.1093/europace/eus390. Epub 2013 Mar 13.
Results Reference
derived

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Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure

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