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A study testing a new heart scan method to improve pacemaker treatment for heart failure

Evaluation of first-phase ejection fraction to guide cardiac resynchronisation therapy-a randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41720362
Enrollment
400
Registered
2025-08-28
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac resynchronisation therapy, heart failure Circulatory System

Interventions

People with heart failure who are referred for a special pacemaker treatment called cardiac resynchronisation therapy (CRT) will be invited to take part. Everyone will have their usual heart assessmen

Sponsors

King's College London
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 22/06/2026: 1. Age =18 years 2. Good understanding of English 3. Receiving optimal medical therapy for heart failure 4. Fulfilling current guideline criteria for cardiac resynchronisation therapy (CRT), including CRT-P, CRT-D, and conduction system pacing (NYHA Class II–IV, LVEF =35%, and QRS duration >130 ms) _____ Previous key inclusion criteria: 1. Age over 18 years 2. Strong understanding of English 3. On optimal medical therapy for heart failure 4. Fulfilling standard consensuses guidelines (NYHA class II-IV, EF =35% and QRS duration>130ms) for CRT ( including conduction pacing system)

Exclusion criteria

Exclusion criteria: Current key exclusion criteria as of 22/06/2026: 1. Co-morbidity expected to reduce life expectancy to less than 6 months 2. Major cardiovascular event within the previous 6 weeks 3. More than mild aortic stenosis 4. Continuous or intermittent infusion therapy for heart failure 5. Suboptimal ultrasound acoustic window 6. Inability to provide informed consent 7. Current participation in another interventional study that, in the opinion of the Chief Investigator, may interfere with the objectives or assessments of this study _____ Previous key exclusion criteria: 1. Co-morbidity expected to reduce life expectancy to less than 6 months 2. Major cardiovascular event in the previous 6 weeks 3. More than mild aortic stenosis 4. Continuous or intermittent infusion therapy for heart failure 5. Suboptimal ultrasound acoustic window 6. Inability to give informed consent 7. Current participant in other interventional studies

Design outcomes

Primary

MeasureTime frame
Volumetric response measured as a reduction in left ventricular end-systolic volume >15% using echocardiography at 6 months after CRT implantation. Clinical improvement measured using the Clinical Composite Score (CCS) at 6 months after CRT implantation

Secondary

MeasureTime frame
Hospitalisation for heart failure or death (clinical events reviewed from patient medical records and telephone call) at 36 months after CRT implantation

Countries

England, United Kingdom

Contacts

Public ContactHaotian Gu
haotian.gu@kcl.ac.uk+44(0)2071884700

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026