A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure (EFFECT-CRT)

King's College London

Status: Not yet enrolling

Conditions: Heart Failure; Cardiac Resynchronisation Therapy (CRT)

Treatments: Other: EF1 guided CRT optimisation; Other: Standard of Care (SOC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07084467

25/LO/0562

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Receiving continuous or intermittent infusion therapy for heart failure
• Poor ultrasound acoustic window preventing adequate imaging
• Unable to give informed consent
• Currently participating in another interventional study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups

Standard of Care

Active Comparator group

Treatment:

Other: Standard of Care (SOC)

EF1 optimisation

Experimental group

Treatment:

Other: EF1 guided CRT optimisation