The Use of Advanced Imaging in HFpEF

NCT06905405 | Recruiting

• 2 other identifiers: STH23163232436D
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The number (proportion) of patients presenting to the HF clinic who do not currently meet the standard criteria for the diagnosis of HFpEF based on standard TTE assessment that have evidence of HFpEF on advanced imaging.

  18 months

Secondary Outcomes (1)

• Secondary Outcome

  18 months

Study Arms (2)

No therapy intervention

cMRI \& TTE, no further intervention

Diagnostic Test: Advanced imaging

Therapy intervention

cMRI \& TTE, SGLT-2 inhibitor therapy

Diagnostic Test: Advanced imaging; Drug: SGLT-2 inhibitor

Interventions

Advanced imaging DIAGNOSTIC_TEST

Cardiac MRI scan Transthoracic ECHO

Also known as: TTE, cMRI

No therapy intervention; Therapy intervention

SGLT-2 inhibitor DRUG

SGLT-2 inhibitor

Therapy intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have been referred to a cardiology clinic with symptoms that may be suggestive of HFpEF, such as breathlessness or fluid overload, but who didn't meet the criteria for diagnosis based on standard imaging.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (2)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

RECRUITING

University of Sheffield

Sheffield, S10 2TN, United Kingdom

NOT YET RECRUITING

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

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

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

GB (2)