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

Официальное название

Evaluation of First-Phase Ejection Fraction to Guide Cardiac Resynchronization Therapy - A Randomised Controlled Trial

Обзор

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.

Вмешательства

• Другое 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.
• Другое Standard of Care (SOC)
  This group will receive standard of care for their health condition and CRT management.

Первичные конечные точки

• Volumetric response of left ventricle [Срок оценки: 6 months post CRT implantation or 6 months post CRT optimisation]

Вторичные конечные точки (1)

• Hospitalization for heart failure or all-cause death [Срок оценки: From enrollment to 36 months post CRT implantation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Guy's and St. Thomas' NHS Foundation Trust — London

Публикации

• 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

Идентификаторы

NCT: NCT07084467 · 25/LO/0562

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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