Role of Cardiac Computed Tomography in Optimising Response to Cardiac Resynchronisation Therapy

NCT ID: NCT02434159

Last Updated: 2015-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Scan

Heart scan prior to device insertion

Group Type ACTIVE_COMPARATOR

Heart scan

Intervention Type OTHER

No scan

No heart scan prior to device insertion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Heart scan

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age \> 18, \<90
2. Patients with moderate or severe heart failure ( NYHA functional class II-IV) due to ischaemic or non-ischaemic cardiomyopathy.
3. QRS duration \>120ms on 12 lead ECG
4. LVEF \< 35%
5. LVEDD \>55 mm
6. Patients on optimum medical treatment for heart failure. The doses of these medications have been stable for 3 months.

Exclusion Criteria

1. Patients with a cardiac or cerebral ischemic event within the previous three months prior to recruitment
2. Patients who had had an atrial arrhythmia within one month prior to recruitment
3. Patients with a systolic blood pressure of more than 170 or less than 80 mm Hg
4. Patients with a heart rate of more than 140 beats per minute
5. Patients with severe renal failure (eGFR \< 30)
6. Patients with a history of allergy to iodine based contrast agents
7. Predicted life expectancy \< 1 year
8. Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University College London Hospital

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Vanessa Cobb

Role: CONTACT

Facility Contacts

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Vanessa Cobb

Role: primary

Other Identifiers

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11/0583

Identifier Type: -

Identifier Source: org_study_id

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