The Use of Advanced Imaging in HFpEF

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSheffield Teaching Hospitals NHS Foundation Trust

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Advanced imaging

    Diagnostic test

    Cardiac MRI scan Transthoracic ECHO

  • SGLT-2 inhibitor

    Drug

    SGLT-2 inhibitor

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: No therapy intervention1 intervention
Group B: Therapy intervention2 interventions

Trial outcomes

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.

Time frame
18 months

Secondary outcomes

1

Secondary Outcome

As a secondary outcome, we will assess the relationship (correlation) between advanced imaging metrics and QoL and exercise capacity. The following metrics will be assessed: * Imaging outcome measures (TTE derived, CMR derived) * Clinical outcome measures (6MWT / KCCQ QoL / EQ-5D-5L QoL)

Time frame
18 months

Other outcomes

Sponsors and contacts

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