- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07320677
Finding Heart Failure in Those Prescribed Loop Diuretics in Primary Care in Jersey (FIND HF LOOP)
Finding Heart Failure in Those Prescribed Loop Diuretics in Primary Care in Jersey (FIND-HF LOOP)
The goal of this clinical trial is to learn whether a simple blood test screening pathway can help diagnose heart failure earlier in adults in primary care who take loop diuretic medicines (such as furosemide or bumetanide) but do not have a recorded diagnosis of heart failure.
The main questions it aims to answer are:
- Does offering a NT-proBNP blood test to eligible patients increase the number of new heart failure diagnoses within 12 months compared with usual care?
- Does this screening pathway also uncover other important heart problems, such as irregular heart rhythms (arrhythmias) or valve disease?
This is a cluster randomised controlled trial, which means that whole GP practices, rather than individual patients, are randomly assigned to one of two approaches:
- NT-proBNP screening pathway, in which eligible patients are invited for a NT-proBNP blood test
- Usual care, in which patients continue to be managed as they normally would without proactive screening
Participants will:
Be identified from GP records if they are prescribed loop diuretics and have no prior diagnosis of heart failure
In screening practices, be invited to attend for a free finger-prick NT-proBNP blood test and brief questionnaire
Be referred to the heart failure team and invited for an echocardiogram (a heart ultrasound scan) and further assessment if their NT-proBNP level is higher than 125 pg/mL
Researchers will compare outcomes between screening and usual-care practices after 12 months, focusing on new diagnoses of heart failure. They will also look at other important cardiovascular findings, such as new arrhythmias, valve disease, and heart failure hospitalisation rates.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Saint Helier, Jersey
- Jersey General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Receiving a loop diuretic (furosemide, bumetanide or torsemide)
- No coded diagnosis of heart failure in GP records
- Never had a natriuretic peptide test
- Willing to have a blood test for NT-proBNP
Exclusion Criteria:
- Clinical Frailty Score 7 or above on Rockwood frailty scale
- Prior diagnosis of heart failure
- Prior natriuretic peptide testing
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention - NTproBNP Screening
Half of the island's GP surgeries will be randomly allocated to the intervention arm, whereby patients receiving a loop diuretic but without a diagnosis of heart failure or natriuretic peptide testing will be invited for a point of care NT-proBNP test.
|
Patients in the intervention arm will be invited for a free point of care NT-proBNP blood test
|
|
No Intervention: Control - Usual care
Half of the island's GP surgeries will be randomly allocated to the control arm, whereby patients will continue with usual clinical care and won't be approached by the study team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
New Heart Failure diagnosis at 12 months
Time Frame: 12 months from practice enrollment
|
12 months from practice enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All cause mortality
Time Frame: 12 months
|
12 months
|
|
|
New clinically relevant cardiovascular disease
Time Frame: 12 months
|
This will include moderate valvular disease and arrhythmia (eg, AF).
|
12 months
|
|
Heart Failure Hospitalisations
Time Frame: 12 months
|
12 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of patients with heart failure but not coded in primary care record
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025HCJREC03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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