Torsion Optimization to Reduce Symptoms and Improve Outcomes in Non-Responders - Full Text View

Sponsors and Collaborators:	University of Calgary Heart and Stroke Foundation of Ontario
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00867984

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Other: Torsion optimized Other: Usual Care	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

dyssynchrony and torsion [ Time Frame: Follow-up (3-6 months) vs. baseline ] [ Designated as safety issue: No ]
mitral regurgitation [ Time Frame: Follow-up (3-6 months) vs. baseline ] [ Designated as safety issue: No ]
N-terminal BNP level [ Time Frame: Follow-up (3-6 months) vs. baseline ] [ Designated as safety issue: No ]
quality of life [ Time Frame: Follow-up (3-6 months) vs. baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Torsion-guided VV optimization plus AV optimization.	Other: Torsion optimized Torsion optimized VV timing plus AV optimization (VTI)
2: Active Comparator AV optimization only.	Other: Usual Care AV optimization (VTI) only

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867984

Contacts

Contact: Derek V Exner, MD, MPH	403.220.3219	exner@ucalgary.ca
Contact: Karen Cowan, RN	403.220.2217	kcowan@ucalgary.ca

Locations

Canada, Alberta
University of Calgary	Recruiting
Calgary, Alberta, Canada, T2N 4N1

Sponsors and Collaborators

University of Calgary

Heart and Stroke Foundation of Ontario

Investigators

Principal Investigator:

Derek V Exner, MD, MPH

University of Calgary

More Information

No publications provided

Responsible Party:	University of Calgary ( Derek Exner )
Study ID Numbers:	7345220000
Study First Received:	March 20, 2009
Last Updated:	March 23, 2009
ClinicalTrials.gov Identifier:	NCT00867984 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Calgary:

CRT, resynchronization,

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2009