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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2030-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Resynchronisation Therapy (CRT) Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

This study will use single masking, meaning participants will not know whether they are in the EF1-guided or standard care group. The medical team adjusting the devices will know the group assignments because of the procedure involved. However, the investigators assessing echocardiograms and clinical results and outcomes will remain unaware (masked) of group assignments.

Study Groups

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Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type OTHER

This group will receive standard of care for their health condition and CRT management.

EF1 optimisation

Group Type EXPERIMENTAL

EF1 guided CRT optimisation

Intervention Type OTHER

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.

Interventions

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EF1 guided CRT optimisation

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.

Intervention Type OTHER

Standard of Care (SOC)

This group will receive standard of care for their health condition and CRT management.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No