A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure

N/ANot Yet RecruitingNCT07084467

King's College London400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

400

Conditions

Cardiac Resynchronisation Therapy (CRT)Heart Failure

Interventions

In the EF1-guided optimisation group, the settings of the CRT device are adjusted to maximise early heart pumping efficiency, measured by a parameter called first-phase ejection fraction (EF1). Depending on the patient's heart rhythm, either the timing between heart chambers (AV or VV delay) is adjusted in small steps. The device setting that gives the best EF1 reading is chosen to help improve the heart's response to CRT.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Volumetric response of left ventricle

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.

Time frame: 6 months post CRT implantation or 6 months post CRT optimisation

Secondary Outcomes

Hospitalization for heart failure or all-cause death

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.

Time frame: From enrollment to 36 months post CRT implantation