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Congestive Heart FailurePhase 2/3TRUST CRTNCT00814840

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

A Phase 2/3 study testing Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads and Triple-site cardiac resynchronization in people with Congestive Heart Failure and Heart Disease, run by Silesian Centre for Heart Diseases at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Congestive Heart Failure, Heart Disease
What is being tested?
Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads and Triple-site cardiac resynchronization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePoland
Study dates
Feb 2008to Jan 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

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

    Zabrze, 41-800

Other trials in Poland

About this study

Official title: Triple-Site Versus Standard Cardiac Resynchronization Therapy (TRUST CRT) Randomized Trial

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.

Being tested
Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads, Triple-site cardiac resynchronization
Keywords
Heart failure, Dyssynchrony, Cardiac resynchronization, Triple-site pacing
Medical subject headings
Heart Failure, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leadsDevice

    Cardiac resynchronization with two intraventricular leads: one in the right ventricle and one in the left ventricle (via the coronary sinus)

  • Triple-site cardiac resynchronizationDevice

    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)

Study groups in NCT00814840
Study groupRoleWhat they receive
Triple-site groupActive comparatorTriple-site resynchronization group
Receives: Device: Triple-site cardiac resynchronization
Standard resynchronization groupActive comparatorStandard (double-site) resynchronization group
Receives: Device: Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: six months

Secondary outcomes (1)

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

    Measured: five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJul 2010
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00814840
Sponsor's protocol ID
SilesianCHD-KNW-6501-3/08
Acronym
TRUST CRT
Status last verified
Apr 2016
First submitted
22 Dec 2008
Last updated
13 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18242737

  • 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.

    PubMed 17631515

  • 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.

    PubMed 18402900

  • 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.

    PubMed 19635069

  • 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.

    PubMed 22651239

  • 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.

    PubMed 25319879

  • 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.

    PubMed 24626998

  • 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.

    PubMed 23487543

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads and Triple-site cardiac resynchronization in people with Congestive Heart Failure and Heart Disease, run by Silesian Centre for Heart Diseases at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00814840, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.

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