FIND HF: Risk-guided Screening for Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Leeds
- Enrollment
- 475
- Primary Endpoint
- To determine whether detection rates of a composite of asymptomatic LVSD, HFrEF, HFmREF, or HFpEF during diagnostics are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk
Study Overview
Brief Summary
The goal of this clinical trial is to learn if the FIND HF algorithm detection rates of heart failure during testing are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk in a population identified as at risk of undiagnosed heart failure. The main questions it aims to answer are:
- Are people who are identified as high risk by the FIND-HF tool more likely to be diagnosed with heart problems during testing than those identified as low risk?
- Are people identified as high risk by the FIND-HF tool more likely to show signs of heart problems during testing than those identified as low risk?? Researchers will compare patients in the high risk and low risk groups to see if more patients are detected with asymptomatic heart failure in the high risk group compared to the low risk group.
Participants will attend one visit at a local clinic where they will undergo an NT proBNP blood test which indicates heart failure and an echocardiogram to evaluate the heart's chambers, valves and overall function to help diagnose various heart conditions.
Detailed Description
Background Heart failure (HF) affects around 1-2% of adults globally and is a leading cause of unplanned hospital admissions, especially among older people. In the UK alone, over one million people have HF, with about 200,000 new cases each year. This increase is mainly due to an aging population and better survival rates following heart attacks.
From the perspective of treatment, there are three main categories of HF:
- HF with reduced ejection fraction (HFrEF)
- HF with mid-range ejection fraction (HFmrEF)
- HF with preserved ejection fraction (HFpEF) For HFrEF, four pillar therapy (diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, lanoxin) is established as the gold standard for pharmacotherapeutic management, helping to reduce the risk of death and hospital admissions. For HFpEF and HFmrEF, medications like empagliflozin, dapagliflozin, and finerenone have shown promising results in reducing risks. New drugs like Semaglutide and Tirzepatide are also beneficial for HFpEF patients with obesity. There are now more treatment options for HF than ever before.
In the UK, nurse-led teams in the community are capable of initiating and adjusting HF treatments. However, diagnosing HF early, before severe symptoms appear, remains challenging. Current guidelines recommend specific tests for diagnosis, but many (8 out of 10) diagnoses are still made in hospitals, often late.
The NHS aims to improve early diagnosis in primary care to reduce hospital admissions and improve patients' quality of life.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Registered with a doctor practice that uses electronic health system to record patient medical notes Age at enrolment greater or equal to 40 Identified as at risk of developing Heart Failure
Exclusion Criteria
- •Registered with a doctor practice that is participating in research studies relating to heart failure screening
- •Known diagnosis of HF
- •On the palliative care register
- •Unable to give written informed consent for participation in the study
- •Unable to adhere to the study requirements
Arms & Interventions
Patients at risk of developing Heart Failure
Patients will attend one visit with a Cardiology specialist Clinical research fellow who will carry out tests to detect Heart Failure
Intervention: FIND HF algorithm (Diagnostic Test)
Outcomes
Primary Outcomes
To determine whether detection rates of a composite of asymptomatic LVSD, HFrEF, HFmREF, or HFpEF during diagnostics are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk
Time Frame: Through study completion, an average of 12 months from date of enrolment
Odds ratio of asymptomatic LVSD, HFrEF, HFmREF, or HFpEF detection rates from intervention in people identified as high HF risk compared with people identified as low HF risk
Secondary Outcomes
- To determine if components of composite outcome during diagnostics are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk(Through study completion, an average of 12 months from date of enrolment)
Investigators
Prof Christopher Gale
Professor of Cardiovascular Medicine
University of Leeds