QUAD-HF - Prospective Registry of Patients With Incident Heart Failure and Left Ventricular Ejection Fraction <50%
NCT ID: NCT07174362
Last Updated: 2025-12-16
Study Results
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Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2025-10-06
2031-11-30
Brief Summary
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Detailed Description
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The management of heart failure however is a true success story of modern medicine. Four decades of randomised clinical trials, provide the evidence base for an extensive catalogue of disease-modifying pharmacological and device treatments that have improved prognosis, particularly in patients with HF and a reduced LVEF \<50%.
However, controlled studies tend to evaluate treatments in selected patient cohorts defined by strict trial inclusion criteria and often exclude older patients, include less women and patient background is often non-diverse. Furthermore, while within clinical trials these treatments are readily available and delivered to patients in meticulous and tightly controlled settings, this does not usually reflect real-world clinical environments, where there may be resource deficiencies. Indeed, a recent cross-sectional survey of hospital-based HF services in the UK, demonstrates wide variation in access to treatment and services. It is therefore important to evaluate the utilization of these treatments and adherence to practice guidelines in a real-world setting.
In England \& Wales, a National Heart Failure Audit collects data in patients with HF who have unplanned hospitalisations for worsening symptoms. This does not extend outside of hospital settings, where the majority of patients time is spent managing their condition. The UK HFpEF study is an ongoing study which caters for patients who have heart failure with a preserved left ventricular ejection fraction (\>50%).
There is however no readily available database or registry outside of hospital, that provides contemporaneous information about the care, changes in management or long-term outcomes for patients with HF and a left ventricular ejection fraction of \<50%, as exists in other healthcare systems.
The QUAD-HF registry is designed as a UK multi-centre, prospective longitudinal registry and would enrol adult patients (\>18 years) who present with incident heart failure and a left ventricular ejection fraction \<50%. NHS secondary or primary care centres in the United Kingdom would be invited to enroll patients into the registry if they have an established HF clinic that routinely documents patient characteristics and pharmacological therapy at each visit. Site selection would be by the steering committee.
Consecutive ambulatory patients attending these clinics, would be approached by managing clinicians; usually specialist HF nurses or cardiologists; to participate. For those hospitalized at the time of their new diagnosis, this approach would be by treating clinician when they are clinically stable. All patients would be treated according to contemporary guidelines.
In the initial phase of the study (1st 12 months), investigators aim to recruit 10 sites, with each site expected to enroll 100 patients into the study over 18 months. Additional sites will be invited as the registry develops. Selection of sites will be determined by the Steering Committee. At that recruitment rate and with additional sites added, investigators expect to onboard approximately 4000 participants into the registry by month 60.
Participants will provide oral and written informed consent to enable future data linkage of data relevant to their past and future health from medical, health, social care and other health-related records, which are collected or held in local, regional and national systems. The study has received ethical approval from the Cambridgeshire South Research Ethics Committee (25/EE/0088) and local research and development departments of participating hospitals.
Broadly, the registry will evaluate the implementation of current HF guidelines and assess the quality of care in daily clinical practice in these patients. The primary clinical endpoint is a composite of cardiovascular mortality and hospitalization for heart failure, 1 year after diagnosis. Secondary endpoints include components of the primary endpoint, all-cause mortality, QUAD score at final therapy titration, days alive out of hospital, time to first HF-related hospitalization and patient-reported outcome measures.
The QUAD-HF registry would provide longitudinal analysis of profiles, management and outcomes for patients with incident HF and a left ventricular ejection fraction of \<50% and provide a platform to support improved knowledge, the development of personalized care and support future research for these patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed Heart Failure with a Left Ventricular Ejection Fraction \<50% (≤12 Weeks prior to enrolment).
3. Able and willing to consent.
Exclusion Criteria
2. Palliative care
3. Unable or unwilling to give consent
18 Years
ALL
No
Sponsors
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Anglia Ruskin University
OTHER
British Society for Heart Failure
UNKNOWN
Mid and South Essex NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Henry Oluwasefunmi Savage
Role: PRINCIPAL_INVESTIGATOR
Mid and South Essex NHS Foundation Trust
Locations
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Mid and South Essex NHS Foundation Trust
Basildon, Essex, United Kingdom
British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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UK HFpEF Collaborative Group. Rationale and design of the United Kingdom Heart Failure with Preserved Ejection Fraction Registry. Heart. 2024 Feb 12;110(5):359-365. doi: 10.1136/heartjnl-2023-323049.
National Institute for Cardiovascular Outcomes Research (NICOR). https://www.nicor.org.uk/~documents/route%3A/download/2765. 2024 [cited 2025 Jan 30]. National Heart failure Audit (NHFA) 2024 Summary Report.
Nallamothu BK, Hayward RA, Bates ER. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation. 2008 Sep 16;118(12):1294-303. doi: 10.1161/CIRCULATIONAHA.107.703579. No abstract available.
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
Related Links
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Health Research Authority, Research Summary Page
Other Identifiers
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354730
Identifier Type: -
Identifier Source: org_study_id