NCT07174362

Brief 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%. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
67mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Oct 2025Nov 2031

First Submitted

Initial submission to the registry

September 12, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

October 6, 2025

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2031

Last Updated

December 16, 2025

Status Verified

September 1, 2025

Enrollment Period

5.1 years

First QC Date

September 12, 2025

Last Update Submit

December 8, 2025

Conditions

Keywords

Observational CohortHeart FailureLongitudinal

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular Mortality or Hospitalization for Heart Failure

    Death due to cardiac causes or hospitalization due to worsening heart failure symptoms

    From enrolment to 12 months after diagnosis

Secondary Outcomes (3)

  • All-cause mortality

    From enrolment to 12 months after diagnosis

  • Cardiovascular Mortality

    From enrolment to 12 months after diagnosis

  • Hospitalization for Heart Failure

    From enrolment to 12 months after diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age \>18 years
  • Newly diagnosed Heart Failure with a Left Ventricular Ejection Fraction \<50% (≤12 Weeks prior to enrolment).
  • Able and willing to consent.

You may not qualify if:

  • LVEF 50% or more at time of diagnosis
  • Palliative care
  • Unable or unwilling to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mid and South Essex NHS Foundation Trust

Basildon, Essex, SS16 5NL, United Kingdom

RECRUITING

British Heart Foundation Glasgow Cardiovascular Research Centre, Glasgow

Glasgow, United Kingdom

NOT YET RECRUITING

Related Publications (5)

  • 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.

    PMID: 37827557BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 18794402BACKGROUND
  • 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.

    PMID: 35363499BACKGROUND
  • 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.

    PMID: 34447992BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Henry Oluwasefunmi Savage

    Mid and South Essex NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Oluwasefunmi Savage, MD FRCP

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 15, 2025

Study Start

October 6, 2025

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2031

Last Updated

December 16, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations