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

University College London (UCL)

Status: Unknown

Conditions: Heart Failure

Treatments: Other: Heart scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02434159

11/0583

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Scan

Active Comparator group

Description:

Heart scan prior to device insertion

Treatment:

Other: Heart scan

No scan

No Intervention group

Description:

No heart scan prior to device insertion