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

NCT07084467 | Not Yet Recruiting

• 1 other identifier: 25/LO/0562
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronisation Therapy (CRT); Heart Failure

Outcome Measures

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.

  6 months post CRT implantation or 6 months post CRT optimisation

Secondary Outcomes (1)

• Hospitalization for heart failure or all-cause death

  From enrollment to 36 months post CRT implantation

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care (SOC)

EF1 optimisation

EXPERIMENTAL

Other: EF1 guided CRT optimisation

Interventions

EF1 guided CRT optimisation 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.

EF1 optimisation

Standard of Care (SOC) OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• 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

Study Sites (1)

Guy's and St. Thomas' NHS Foundation Trust

London, United Kingdom

Location

Related Publications (6)

• 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.116.08545. Epub 2017 Feb 21.

  PMID: 28223475 BACKGROUND

• 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 BACKGROUND

• 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 Preclinical Heart Failure, Is Strongly Associated With Increased Mortality in Patients With COVID-19. Hypertension. 2021 Jun;77(6):2014-2022. doi: 10.1161/HYPERTENSIONAHA.121.17099. Epub 2021 May 10.

  PMID: 33966447 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017 Aug 8;136(6):e137-e161. doi: 10.1161/CIR.0000000000000509. Epub 2017 Apr 28. No abstract available.

  PMID: 28455343 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Haotian Gu, PhD

CONTACT

+44(0)2071884700; haotian.gu@kcl.ac.uk

Phil Chowienczyk, PhD

CONTACT

phil.chowienczyk@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)