NCT05955456

Brief Summary

Heart failure represents a growing public health problem within the UK and particularly within the North West of England. A major challenge is that heart failure is currently diagnosed too late. The researchers have previously developed a risk calculator that accurately identifies individuals at risk of heart failure admission or death before they have developed heart failure. Most risk calculators are never implemented into clinical practice. The researchers will l perform a pilot study to evaluate the risk calculator within primary care in Greater Manchester.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
52mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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 Progress38%
Oct 2023Sep 2030

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 9, 2023

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

6.9 years

First QC Date

July 13, 2023

Last Update Submit

September 26, 2025

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Preliminary measures of risk calculator validation and accuracy in Greater Manchester

    Risk calculator will predict incident heart failure, first heart failure hospitalisation, cardiovascular death and all cause death

    5 years

Secondary Outcomes (6)

  • Qualitative measures of primary care uptake and engagement

    5 years

  • Proportion of participants recruited from socioeconomically deprived and ethnically diverse backgrounds

    5 years

  • Measures of prognostic model calibration and discrimination in a primary care population

    5 years

  • Measures of prognostic model optimisation and accuracy with iterative variable inclusion or exclusion

    5 years

  • Causal statistical analysis to determine effect of hypothetical interventions

    5 years

  • +1 more secondary outcomes

Study Arms (1)

Participants in primary care with risk factors for heart failure

Other: No intervention

Interventions

No interventionOTHER

No intervention is applied to participants. The risk calculator score is not released to the participants or care providers. Participants are followed up for risk calculator accuracy and recalibration.

Participants in primary care with risk factors for heart failure

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care population with risk factors for heart failure

You may qualify if:

  • Written informed consent
  • Aged 50 and over
  • Two or more of the following conditions: type 2 diabetes, chronic obstructive pulmonary disease, ischaemic heart disease, atrial fibrillation, hypertension, chronic kidney disease stage 3, body mass index ≥ 30 kg/m2

You may not qualify if:

  • Established diagnosis of one or more of the following: heart failure, cardiomyopathy, moderate or severe valvular heart disease, congenital heart disease, heart transplant, idiopathic, heritable or drug-induced pulmonary arterial hypertension, any medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
  • Contraindication to cardiovascular magnetic resonance (CMR) scanning, including pacemaker, defibrillator, intraocular metal, intracranial aneurysm clips, severe claustrophobia, estimated glomerular filtration rate \< 30 ml/min/1.73m2, previous severe allergic reaction or anaphylaxis to gadolinium-based contrast agent, pregnancy or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, m13 9wl, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

October 9, 2023

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2030

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

GB(1)