Cardiac Resynchronisation Therapy (CRT), Heart Failure
Conditions
Brief summary
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.
Interventions
OTHEREF1 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.
OTHERStandard of Care (SOC)
This group will receive standard of care for their health condition and CRT management.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
King's College Hospital NHS Trust
Barts Helth NHS Trust
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volumetric response of left ventricle | 6 months post CRT implantation or 6 months post CRT optimisation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization for heart failure or all-cause death | From enrollment to 36 months post CRT implantation | 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. |
Countries
United Kingdom
Contacts
Primary ContactHaotian Gu, PhD
Backup ContactPhil Chowienczyk, PhD
Outcome results
None listed