Torsion Optimization to Reduce Symptoms and Improve Outcomes in Non-responders (TORSION)
Primary Purpose
Heart Failure, Congestive
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Torsion optimized
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring CRT, resynchronization,
Eligibility Criteria
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.
Sites / Locations
- University of Calgary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Torsion-guided VV optimization plus AV optimization.
AV optimization only.
Outcomes
Primary Outcome Measures
Improved functional class (≥ 1 class) & remodeling (either ≥ 10% relative reduction in LV ESV or a ≥ 5% absolute increase in LV EF).
Secondary Outcome Measures
dyssynchrony and torsion
mitral regurgitation
N-terminal BNP level
quality of life
Full Information
NCT ID
NCT00867984
First Posted
March 20, 2009
Last Updated
November 20, 2015
Sponsor
University of Calgary
Collaborators
Heart and Stroke Foundation of Canada
1. Study Identification
Unique Protocol Identification Number
NCT00867984
Brief Title
Torsion Optimization to Reduce Symptoms and Improve Outcomes in Non-responders
Acronym
TORSION
Official Title
Torsion Optimization to Reduce Symptoms and Improve Outcomes in Non-responders (TORSION). A Randomized Comparison of Torsion-imaging Guided Optimization vs. Usual Settings.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Heart and Stroke Foundation of Canada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
CRT, resynchronization,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Torsion-guided VV optimization plus AV optimization.
Arm Title
2
Arm Type
Active Comparator
Arm Description
AV optimization only.
Intervention Type
Other
Intervention Name(s)
Torsion optimized
Intervention Description
Torsion optimized VV timing plus AV optimization (VTI)
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
AV optimization (VTI) only
Primary Outcome Measure Information:
Title
Improved functional class (≥ 1 class) & remodeling (either ≥ 10% relative reduction in LV ESV or a ≥ 5% absolute increase in LV EF).
Time Frame
Follow up (3-6 months) versus baseline.
Secondary Outcome Measure Information:
Title
dyssynchrony and torsion
Time Frame
Follow-up (3-6 months) vs. baseline
Title
mitral regurgitation
Time Frame
Follow-up (3-6 months) vs. baseline
Title
N-terminal BNP level
Time Frame
Follow-up (3-6 months) vs. baseline
Title
quality of life
Time Frame
Follow-up (3-6 months) vs. baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek V Exner, MD, MPH
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
12. IPD Sharing Statement
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Torsion Optimization to Reduce Symptoms and Improve Outcomes in Non-responders
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