Clinical trial NCT00814840: Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure
Official title: Triple-Site Versus Standard Cardiac Resynchronization Therapy (TRUST CRT) Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Congestive Heart Failure
Heart Disease
Keywords: Heart failure
Dyssynchrony
Cardiac resynchronization
Triple-site pacing
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
First posted: 2008-12-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: six months
Secondary outcomes:
measure: The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death).
timeFrame: five years
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
Study officials:
affiliation: First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
name: Radosław Lenarczyk, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
name: Zbigniew Kalarus, M.D.
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.