Health TrialsbyHealthPanel

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

ConditionsCardiac Resynchronisation Therapy (CRT)Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing's College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

On optimal medical therapy for heart failure

NYHA class II to IV

Left ventricular ejection fraction (EF) ≤ 35%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • EF1 guided CRT optimisation

    Other intervention

    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.

  • Standard of Care (SOC)

    Other intervention

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: EF1 optimisationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College London

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator

The Leeds Teaching Hospitals NHS Trust

Collaborator

King's College Hospital NHS Trust

Collaborator

Barts Helth NHS Trust

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: