NCT07084467Not yet recruiting
A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure
Evaluation of First-Phase Ejection Fraction to Guide Cardiac Resynchronization Therapy - A Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Jul 2030
- Lead sponsor
- King's College London
- Diseases
- Heart failure
- NCT number
- NCT07084467
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 1 Aug 2025 to the primary completion date, 31 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving continuous or intermittent infusion therapy for heart failure
Other
- Co-morbidities likely to reduce life expectancy to less than 6 months
- Major cardiovascular event within the past 6 weeks
- More than mild aortic stenosis
- Poor ultrasound acoustic window preventing adequate imaging
- Unable to give informed consent
- Currently participating in another interventional study
Who the study is looking for
- Age 18 years or older
- On optimal medical therapy for heart failure
- Meets standard guideline criteria for CRT (including conduction system pacing), specifically:
- NYHA class II to IV
- Left ventricular ejection fraction (EF) ≤ 35%
- QRS duration \> 130 ms
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guy's and St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.