A Study Testing a New Heart Scan Method to Improve Pacemaker Treatment for Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EF1 guided CRT optimisation, Standard of Care (SOC).
- Who it may be relevant to
- Registry conditions: Cardiac Resynchronisation Therapy (CRT), Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of First-Phase Ejection Fraction to Guide Cardiac Resynchronization Therapy - A Randomised Controlled Trial
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.
Interventions
- Other 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. - Other Standard of Care (SOC)
This group will receive standard of care for their health condition and CRT management.
Primary outcome measures
- Volumetric response of left ventricle [Time frame: 6 months post CRT implantation or 6 months post CRT optimisation]
Secondary outcome measures (1)
- Hospitalization for heart failure or all-cause death [Time frame: From enrollment to 36 months post CRT implantation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- Guy's and St. Thomas' NHS Foundation Trust — London
Publications
- Gu H, Li Y, Fok H, Simpson J, Kentish JC, Shah AM, Chowienczyk PJ. Reduced First-Phase Ejection Fraction and Sustained Myocardial Wall Stress in Hypertensive Patients With Diastolic Dysfunction: A Manifestation of Impaired Shortening Deactivation That Links Systolic to Diastolic Dysfunction and Preserves Systolic Ejection Fraction. Hypertension. 2017 Apr;69(4):633-640. doi: 10.1161/HYPERTENSIONAHA PMID 28223475
- Gu H, Sidhu BS, Fang L, Webb J, Jackson T, Claridge S, Einarsen E, Razavi R, Papageorgiou N, Chow A, Bhattacharyya S, Chowienczyk P, Rinaldi CA. First-Phase Ejection Fraction Predicts Response to Cardiac Resynchronization Therapy and Adverse Outcomes. JACC Cardiovasc Imaging. 2021 Dec;14(12):2275-2285. doi: 10.1016/j.jcmg.2021.05.007. PMID 34886993
- Gu H, Cirillo C, Nabeebaccus AA, Sun Z, Fang L, Xie Y, Demir O, Desai N, He L, Lu Q, Nakou E, O'Gallagher K, Tountas C, Marvaki A, Monaghan M, Perera D, Pericao A, Ryan M, Sinclair H, Stylianidis V, Victor K, Wang B, Wang J, Wang R, Wu C, Yang Y, Yuan H, Zhang D, Zhang Y, Faconti L, Papachristidis A, Zhang L, Carr-White G, Shah AM, Xie M, Chowienczyk P. First-Phase Ejection Fraction, a Measure of PMID 33966447
- Bing R, Gu H, Chin C, Fang L, White A, Everett RJ, Spath NB, Park E, Jenkins WS, Shah AS, Mills NL, Flapan AD, Chambers JB, Newby DE, Chowienczyk P, Dweck MR. Determinants and prognostic value of echocardiographic first-phase ejection fraction in aortic stenosis. Heart. 2020 Aug;106(16):1236-1243. doi: 10.1136/heartjnl-2020-316684. Epub 2020 Apr 28. PMID 32345658
- Gu H, Saeed S, Boguslavskyi A, Carr-White G, Chambers JB, Chowienczyk P. First-Phase Ejection Fraction Is a Powerful Predictor of Adverse Events in Asymptomatic Patients With Aortic Stenosis and Preserved Total Ejection Fraction. JACC Cardiovasc Imaging. 2019 Jan;12(1):52-63. doi: 10.1016/j.jcmg.2018.08.037. Epub 2018 Nov 15. PMID 30448118
- Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Cli PMID 28455343
Identifiers
NCT: NCT07084467 · 25/LO/0562