| NCT ID | NCT06905405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheffield Teaching Hospitals NHS Foundation Trust |
| Condition | Heart Failure With Preserved Ejection Fraction (HFPEF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-08-05 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Heart failure with preserved ejection fraction (HFpEF) causes symptoms of breathlessness and leg swelling. It is associated with significant number of hospital admissions and could lead to the patient's death. In HFpEF, the pumping function of the heart is normal but the heart is too stiff to fill properly. The first line investigation is an ultrasound of the heart (echocardiography). A number of parameters are assessed that indicate stiffness within the heart or raised pressures within the heart. However, most of these parameters lack sensitivity which can make HFpEF difficult to diagnose. The best test is to invasively measure the pressures in the heart at rest and with exercise in a procedure called heart catheterisation. However, this is invasive and not readily available. As a result, HFpEF is significantly under diagnosed meaning many patients do not get access to disease specific treatment that may improve symptoms and quality of life. There are a number of new imaging techniques that may help us to better identify HFpEF . However, it is not currently known how to best apply them in clinical practice. In this study, the investigators will recruit patients presenting to the HF clinic at Sheffield Teaching Hospitals who have symptoms of HFpEF but whose diagnosis remains unclear after initial assessment. The impact of their symptoms will be assessed with the use of a quality of life (QoL) questionnaires and a six-minute walk test (6MWT). They will undergo advanced imaging with a specialist echocardiogram and a cardiac MRI scan. If they are found to have features of HFpEF, they will be started on disease specific treatment. All patients will be followed up after six months to see if they have any symptomatic or functional improvement. They will also undergo repeat imaging to see if there has been any change in the imaging parameters.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06905405 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure With Preserved Ejection Fraction (HFPEF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06905405 currently recruiting?
Yes, NCT06905405 is actively recruiting participants. Visit ClinicalTrials.gov or contact Sheffield Teaching Hospitals NHS Foundation Trust to inquire about joining.
Where is the NCT06905405 trial being conducted?
This trial is being conducted at Sheffield, United Kingdom, Sheffield, United Kingdom.
Who is sponsoring the NCT06905405 clinical trial?
NCT06905405 is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. The trial plans to enroll 40 participants.
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