Using advanced heart imaging to find HFpEF
Assessing the Ability to Improve the Diagnosis of Heart Failure With Preserved Ejection Fraction Using Advanced Imaging Techniques
This project will test if advanced heart imaging and related tests can help diagnose people with breathlessness who have normal heart pumping but suspected HFpEF.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust Academic / other |
| Locations | 2 sites (Sheffield, South Yorkshire and 1 other locations) |
| Trial ID | NCT06905405 on ClinicalTrials.gov |
What this trial studies
Adults with unexplained exertional breathlessness who have an indeterminate standard heart ultrasound and elevated NT‑proBNP will be recruited from the diagnostic heart failure clinic in Sheffield. Enrolled participants must be in sinus rhythm with a dilated left atrium but not meet standard echocardiographic criteria for heart failure, and will be excluded for atrial fibrillation, prior reduced‑EF heart failure, active angina, inability to consent, or contraindications to SGLT2 inhibitors. Participants will complete quality‑of‑life questionnaires (EQ‑5D‑5L and KCCQ), perform two 6‑minute walk tests, and undergo advanced cardiac imaging; results will be compared with standard tests and, where available, invasive haemodynamic reference data. The aim is to determine whether noninvasive imaging markers can identify patients with HFpEF who are currently missed by routine assessment.
Who should consider this trial
Good fit: Adults over 18 with exertional breathlessness, NT‑proBNP >400 ng/L in sinus rhythm, and a dilated left atrium on echocardiography but otherwise inconclusive standard testing are ideal candidates.
Not a fit: Patients with prior reduced ejection fraction heart failure, atrial fibrillation, current angina, inability to consent, or contraindications to SGLT2 inhibitors are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could identify more patients with HFpEF earlier so they can access disease‑specific treatments and potentially improve symptoms and quality of life.
How similar studies have performed: Invasive haemodynamic testing has supported the diagnostic concept, and prior imaging studies have suggested promise, but using advanced noninvasive imaging as a definitive alternative remains under active investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female \> 18yrs of age. * Symptoms of dysponea on exertion. * NTproBNP \>400 ng/L in sinus rhythm (SR). * Baseline TTE demonstrating a dilated LA (LA\>34 ml/m2), but that otherwise does not meet the current criteria for the diagnosis of HFpEF or HFrEF (preserved LV systolic function, Normal E/e', no evidence of LVH, Estimated PAP \< 35mmhg). Exclusion Criteria: * Inability to give informed consent. History of HFrEF * contraindications to SGLT2 inhibitor (a history of type 1 diabetes mellitus, ketoacidosis, allergy to SGLT2 inhibitors, planned or current use of SGLT2 inhibitors or active genital infection). * Atrial Fibrillation. * Current history of anginal chest pain
Where this trial is running
Sheffield, South Yorkshire and 1 other locations
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, South Yorkshire, United Kingdom (Recruiting)
- University of Sheffield — Sheffield, United Kingdom (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.