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Torsion Optimization to Reduce Symptoms and Improve Outcomes in Non-responders

NCT ID: NCT00867984

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2017-01-31

Brief Summary

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Approximately 40% of resynchronization therapy recipients do not appear to clearly benefit. These patients are termed 'non-responders'. This study will assess whether a heart ultrasound (echo) technique called 'torsion imaging' can be used to increase the likelihood of benefit from resynchronization therapy.

Detailed Description

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Background: Despite advances in pharmacotherapy, patients with heart failure (HF) are at high risk for death and hospitalization. Over 25% of patients with systolic HF have dyssynchronous ventricular contraction that impairs left ventricular (LV) function and results in HF progression. Cardiac resynchronization therapy (CRT) is designed to synchronize ventricular mechanical activity, improving cardiac output and reducing HF symptoms. As shown in our pilot data, at least 40% of patients do not respond to CRT despite pre-screening for the presence of longitudinal (long axis) mechanical (velocity) dyssynchrony and targeting LV lead placement to the latest site of latest velocity. Methods to improve the rates of response to CRT are required. Torsion imaging guided optimization of CRT timing is a promising approach and will be tested in this study.

Primary hypothesis: Optimization of inter-ventricular (VV) timing, guided by torsion imaging, will increase functional capacity and reduce LV end systolic volume \[ESV\] in CRT in patients who have not responded after ≥ 6 months. CRT response will be defined by a ≥ 1 functional class improvement and either a ≥ 10% reduction in LV ESV or a ≥ 5% increase in EF at follow-up versus baseline.

Secondary aims: To compare the following in torsion-guided vs usual care patients: a) echo parameters (intra-LV and VV dyssynchrony and torsion, and mitral regurgitation), b) N-terminal BNP levels, and c) generic / disease-specific quality of life.

Methods: Randomized study of patients who have not responded to CRT after ≥ 6 months.

Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Torsion-guided VV optimization plus AV optimization.

Group Type EXPERIMENTAL

Torsion optimized

Intervention Type OTHER

Torsion optimized VV timing plus AV optimization (VTI)

2

AV optimization only.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

AV optimization (VTI) only

Interventions

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Torsion optimized

Torsion optimized VV timing plus AV optimization (VTI)

Intervention Type OTHER

Usual Care

AV optimization (VTI) only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* non-response to CRT as indicated,
* stable doses of ACE I / ARB and beta-blocker for ≥ 2 months, \&
* controlled heart rate if in atrial fibrillation.

Exclusion Criteria

* inadequate images to assess torsion
* no significant augmentation in torsion with optimization
* unable or unwilling to provide informed consent,
* medical condition other than HF likely to cause death within 6 months,
* cardiac transplant planned,
* myocardial infarction or revascularization since CRT implant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Stroke Foundation of Canada

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Dr. Derek Exner

Professor and Canada Research Chair in Cardiovascular Clinical Trials

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derek V Exner, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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7345220000

Identifier Type: -

Identifier Source: org_study_id