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

Heart Failure Clinical Trial

Official title:

Role of Cardiac Computed Tomography and Cardiac Magnetic Resonance in Optimising Response to Cardiac Resynchronisation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02434159
• Other study ID #: 11/0583
• Status: Recruiting
• Phase: N/A
• First received: April 30, 2015
• Last updated: April 30, 2015
• Start date: May 2012

Study information

• Verified date: April 2015
• Source: University College, London
• Contact: Vanessa Cobb
• Email: nesscobb[@]hotmail.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Heart scan

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minute walk test		6 months	No