Assessing the Ability to Improve the Diagnosis of Heart Failure With Preserved Ejection Fraction Using Advanced Imaging Techniques
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Primary Outcome
研究概览
简要总结
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.
详细描述
The investigators will recruit patients from the Diagnostic heart failure (HF) clinic at Northern General Hospital, Sheffield. Patients with symptoms suggestive of HF but with an indeterminate diagnosis after standard assessment will be recruited.
They will be assessed against the following inclusion and exclusion criteria. Inclusion criteria: Male or female > 18yrs of age. Symptoms of shortness of breath on exertion. NTproBNP (blood test of heart failure) >400 ng/L in sinus rhythm (SR). Baseline TTE demonstrating a dilated left atrium (LA>34 ml/m2), but that otherwise does not meet the current criteria for the diagnosis of HF.
Exclusion criteria: Inability to give informed consent. History of HF, 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. All patients will provide written informed consent.
Upon recruitment, all patients will be invited to complete a quality of life questionnaire to assess the burden of their symptoms. The EQ-5Q-5L and KCCQ questionnaires will be used which have widely been used in this patient group.
At the same visit, patients will also undergo a 6-minute walk test (6MWT), repeated twice to mitigate the 'training' effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
No therapy intervention
cMRI & TTE, no further intervention
干预措施: Advanced imaging (Diagnostic Test)
Therapy intervention
cMRI & TTE, SGLT-2 inhibitor therapy
干预措施: Advanced imaging (Diagnostic Test)
Therapy intervention
cMRI & TTE, SGLT-2 inhibitor therapy
干预措施: SGLT-2 inhibitor (Drug)
结局指标
主要结局
Primary Outcome
时间窗: 18 months
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.
次要结局
- Secondary Outcome(18 months)