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

Silesian Centre for Heart Diseases1 site in 1 country100 target enrollmentFebruary 2008

ConditionsCongestive Heart Failure Heart Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Congestive Heart Failure
Sponsor: Silesian Centre for Heart Diseases
Enrollment: 100
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

January 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Silesian Centre for Heart Diseases

Responsible Party

Principal Investigator

Radoslaw Lenarczyk

Primary Investigator

Silesian Centre for Heart Diseases

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,

Outcomes

Primary Outcomes

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 Outcomes

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