Evaluation of EF1 to Guide CRT

Not Applicable

Not yet recruiting

• Conditions: Cardiac Resynchronisation Therapy (CRT); Heart Failure

• Registration Number: NCT07084467
• Lead Sponsor: King's College London

Brief Summary

Cardiac resynchronization therapy (CRT) is a device treatment for patients with heart failure which cannot be managed by medications alone. CRT can help the heart contract more efficiently and improve the pumping function. However, many patients do not benefit from this treatment. Therefore, a better selection tool will help us to determine the most suitable patients to receive this treatment. A new measure of pumping function of the heart called: first-phase ejection fraction or EF1 has been shown a good tool to select suitable patients for CRT. EF1 is a sensitive measurement of heart function and can be easily measured by echocardiography (an ultrasound heart scan).

The purpose of this study is to examine whether this new measurement (EF1) can predict outcomes and response to CRT treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-16
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-08-01
• Primary Completion: 2030-07-31
• Study Completion: 2030-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Age over 18 years with strong understanding of English on optimal medical therapy for heart failure and fulfilling standard consensuses guidelines (NYHA class II-IV, EF ≤35% and QRS duration>130ms) for CRT ( including conduction pacing system)

Exclusion Criteria

Co-morbidity expected to reduce life expectancy < 6 months, major cardiovascular event in the previous 6 weeks, more than mild aortic stenosis, continuous or intermittent infusion therapy for heart failure, suboptimal ultrasound acoustic window and inability to give informed consent, current participant of other interventional studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Volumetric response of left ventricle	6 months post CRT implantation or 6 months post CRT optimisation	This will be defined as a reduction in left ventricular end-systolic volume by more than 15% at following CRT implantation comparing to before CRT implantation on echocardiogram.

Secondary Outcome Measures

Name	Time	Method
Hospitalization for heart failure or all-cause death	From enrollment to 36 months post CRT implantation	This composite endpoint will be collected over the entire duration of follow-up in the trial when the last patient randomized has reached 36 months of follow-up post CRT implantation.

Trial Locations

Locations (1)

Guy's and St. Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom