NCT02434159UnknownNot Applicable
Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University College, London
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 6 minute walk test
Study Overview
Brief Summary
The purpose of this study is to determine if detailed scanning of the heart before biventricular device insertion will improve outcomes for heart failure patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18, <90
- •Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
- •QRS duration >120ms on 12 lead ECG
- •LVEF < 35%
- •LVEDD >55 mm
- •Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.
Exclusion Criteria
- •Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
- •Patients who had had an atrial arrhythmia within one month prior to recruitment
- •Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
- •Patients with a heart rate of more than 140 beats per minute
- •Patients with severe renal failure (eGFR < 30)
- •Patients with a history of allergy to iodine based contrast agents
- •Predicted life expectancy < 1 year
Arms & Interventions
Scan
Active Comparator
Heart scan prior to device insertion
Intervention: Heart scan (Other)
No scan
No Intervention
No heart scan prior to device insertion
Outcomes
Primary Outcomes
6 minute walk test
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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