Heart FailureQUAD-HFNCT07174362
QUAD-HF - Prospective Registry of Patients With Incident Heart Failure and Left Ventricular Ejection Fraction <50%
An observational study of Heart Failure, run by Mid and South Essex NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
The QUAD-HF registry is an observational study that would enroll patients in the United Kingdom, who have been newly diagnosed with heart failure and a left ventricular ejection fraction <50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 4,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Oct 2025to Nov 2031
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible participants would include adult patients (>18 years) attending HF clinics in hospital or community settings or those hospitalized for the management of Acute Decompensated Heart failure (ADHF), who have been newly diagnosed HF with a left ventricular ejection fraction of <50%, no more than 12 weeks prior. Patients would be excluded if they have had a previous diagnosis of heart failure, are on a palliative care pathway or are unable or unwilling to consent.
Who may be able to join
- Age >18 years
- Newly diagnosed Heart Failure with a Left Ventricular Ejection Fraction <50% (≤12 Weeks prior to enrolment).
- Able and willing to consent.
Who cannot join
- LVEF 50% or more at time of diagnosis
- Palliative care
- Unable or unwilling to give consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Mid and South Essex NHS Foundation Trust
Basildon, Essex, SS16 5NL
Georgina Beetar, +44 01268524900, georgina.beetar@nhs.net
Henry Oluwasefunmi Savage, MD MBBS
- Not yet recruiting
British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow
Glasgow
Euan Rennie, +44(0)141 330 2000, euan.rennie@nhs.scot
John G F Cleland, MBChB, MD, FESC, FRCP, FACC
About this study
Official title: QUAD-HF Registry - A Prospective Registry of Patients With Incident Heart Failure and Left Ventricular Ejection Fraction of <50%
The QUAD-HF registry is an observational study that would enroll patients in the United Kingdom, who have been newly diagnosed with heart failure and a left ventricular ejection fraction <50%. We plan to assess clinical outcomes in these patients, such as hospitalization and death, in relation to their diagnosis, implementation of guidelines and type of treatments these patients have received.
Read the detailed description
Heart failure (HF) is a widespread global health challenge, affecting approximately 1 million individuals in the United Kingdom and the prevalence is predicted to almost double in the next decades due to the ageing population. In the United Kingdom, hospitalizations for HF account for 5% of emergency medical admissions with a substantial economic burden.
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
- Heart Failure
- Keywords
- Observational Cohort, Heart Failure, Longitudinal
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Mortality or Hospitalization for Heart Failure
Death due to cardiac causes or hospitalization due to worsening heart failure symptoms
Measured: From enrolment to 12 months after diagnosis
Secondary outcomes (3)
All-cause mortality
Death due to any cause
Measured: From enrolment to 12 months after diagnosis
Cardiovascular Mortality
Death due to cardiac causes
Measured: From enrolment to 12 months after diagnosis
Hospitalization for Heart Failure
Hospitalization due to worsening heart failure symptoms
Measured: From enrolment to 12 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start6 Oct 2025
- Primary completionNov 2030 (estimated)
- Study completionNov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University, British Society for Heart Failure
- Responsible party
- Sponsor
- Investigators
- Henry Oluwasefunmi Savage, Principal investigator, Mid and South Essex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174362
- Sponsor's protocol ID
- 354730
- Acronym
- QUAD-HF
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data from this study cannot be shared publicly, or outside the United Kingdom, due to the restrictions of ethical approval obtained, internal regulations, patient consent, and data regulations. Researchers from within the United Kingdom will require approval from the executive steering committee of the registry, for IPD to be made available. Researchers from outside the United Kingdom interested in collaboration are invited to contact the principal investigator to discuss.
Publications
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.
PubMed 37827557National 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.
PubMed 18794402Heidenreich 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.
PubMed 35363499McDonagh 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.
PubMed 34447992
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QUAD-HF Registry - A Prospective Registry of Patients With Incident Heart Failure and Left Ventricular Ejection Fraction of <50%
- ClinicalTrials.gov ID
- NCT07174362
- Acronym / sponsor ID
- QUAD-HF / 354730
- Conditions
- Heart Failure
- Keywords
- Observational Cohort, Heart Failure, Longitudinal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University, British Society for Heart Failure
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2031 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The QUAD-HF registry is an observational study that would enroll patients in the United Kingdom, who have been newly diagnosed with heart failure and a left ventricular ejection fraction <50%. We plan to assess clinical outcomes in these patients, such as hospitalization and death, in relation to their diagnosis, implementation of guidelines and type of treatments these patients have received.
Detailed description
Heart failure (HF) is a widespread global health challenge, affecting approximately 1 million individuals in the United Kingdom and the prevalence is predicted to almost double in the next decades due to the ageing population. In the United Kingdom, hospitalizations for HF account for 5% of emergency medical admissions with a substantial economic burden.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants would include adult patients (>18 years) attending HF clinics in hospital or community settings or those hospitalized for the management of Acute Decompensated Heart failure (ADHF), who have been newly diagnosed HF with a left ventricular ejection fraction of <50%, no more than 12 weeks prior. Patients would be excluded if they have had a previous diagnosis of heart failure, are on a palliative care pathway or are unable or unwilling to consent.
Key inclusion criteria (3 listed)
- Age >18 years
- Newly diagnosed Heart Failure with a Left Ventricular Ejection Fraction <50% (≤12 Weeks prior to enrolment).
- Able and willing to consent.
Key exclusion criteria (3 listed)
- LVEF 50% or more at time of diagnosis
- Palliative care
- Unable or unwilling to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular Mortality or Hospitalization for Heart Failure
Time frame: From enrolment to 12 months after diagnosis
Death due to cardiac causes or hospitalization due to worsening heart failure symptoms
3 secondary outcomes
All-cause mortality
Time frame: From enrolment to 12 months after diagnosis
Cardiovascular Mortality
Time frame: From enrolment to 12 months after diagnosis
Hospitalization for Heart Failure
Time frame: From enrolment to 12 months after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 37827557UK 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.
- BackgroundNational 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.
- Background: PubMed 18794402Nallamothu 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.
- Background: PubMed 35363499Heidenreich 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.
- Background: PubMed 34447992McDonagh 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.
- Health Research Authority, Research Summary PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Patient Data from this study cannot be shared publicly, or outside the United Kingdom, due to the restrictions of ethical approval obtained, internal regulations, patient consent, and data regulations. Researchers from within the United Kingdom will require approval from the executive steering committee of the registry, for IPD to be made available. Researchers from outside the United Kingdom interested in collaboration are invited to contact the principal investigator to discuss.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Henry Oluwasefunmi Savage principal investigator
Mid and South Essex NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Mid and South Essex NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry Oluwasefunmi Savage, MD FRCP (+44 01268524900, henry.savage@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Mortality or Hospitalization for Heart Failure (time frame: From enrolment to 12 months after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174362, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.