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

NCT00867984 | Unknown Phase 3 DMC

• 1 other identifier: 7345220000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Congestive

Keywords

CRT, resynchronization,

Outcome Measures

Primary Outcomes (1)

• Improved functional class (≥ 1 class) & remodeling (either ≥ 10% relative reduction in LV ESV or a ≥ 5% absolute increase in LV EF).

  Follow up (3-6 months) versus baseline.

Secondary Outcomes (4)

• dyssynchrony and torsion

  Follow-up (3-6 months) vs. baseline

• mitral regurgitation

  Follow-up (3-6 months) vs. baseline

• N-terminal BNP level

  Follow-up (3-6 months) vs. baseline

• quality of life

  Follow-up (3-6 months) vs. baseline

Study Arms (2)

1

EXPERIMENTAL

Torsion-guided VV optimization plus AV optimization.

Other: Torsion optimized

2

ACTIVE COMPARATOR

AV optimization only.

Other: Usual Care

Interventions

Torsion optimized OTHER

Torsion optimized VV timing plus AV optimization (VTI)

1

Usual Care OTHER

AV optimization (VTI) only

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4N1, Canada

Location

MeSH Terms

Conditions

Heart Failure; Creatine deficiency, X-linked

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Derek V Exner, MD, MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Canada Research Chair in Cardiovascular Clinical Trials

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 24, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

CA (1)