Back to resultsRole of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Heart scan
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
- Pregnancy
Sites / Locations
- University College London HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Scan
No scan
Arm Description
Heart scan prior to device insertion
No heart scan prior to device insertion
Outcomes
Primary Outcome Measures
6 minute walk test
Secondary Outcome Measures
Full Information
NCT ID
NCT02434159
First Posted
April 30, 2015
Last Updated
April 30, 2015
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT02434159
Brief Title
Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy
Official Title
Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Scan
Arm Type
Active Comparator
Arm Description
Heart scan prior to device insertion
Arm Title
No scan
Arm Type
No Intervention
Arm Description
No heart scan prior to device insertion
Intervention Type
Other
Intervention Name(s)
Heart scan
Primary Outcome Measure Information:
Title
6 minute walk test
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Cobb
Email
nesscobb@hotmail.com
Facility Information:
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Cobb
Email
nesscobb@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy
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