Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF)

Study Overview
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Brief Summary
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The investigators wish to test a hypothesis that patients with HFpEF have different characteristics on echo, cardiac MRI and plasma protein & chemical profiles compared to HFrEF and healthy volunteers.

Detailed Description
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Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to: better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls) provide mechanistic insights into pathophysiology describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)

Official Title
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Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction

Conditions
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Patients With Heart Failure and Preserved Ejection Fraction - HFpEF, Patients With Heart Failure With Reduced Ejection Fraction - HFrEF, Healthy Controls Group - Age and Sex-matched

Intervention / Treatment
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* Diagnostic Test: MRI scan, Echo scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical features of heart failure or prior radiographic evidence in the absence of symptoms And Either ejection fraction > 50% (for HFpEF arm) or ejection fraction < 40% (for HFrEF arm) Exclusion Criteria: Myocardial infarction within the preceding 6 months Suspected or confirmed cardiomyopathy (e.g. hypertrophic, infiltrative) Suspected or confirmed constrictive pericarditis Significant native valve disease (≥ moderate severity) Known Significant lung disease (documented or FEV1< 30% or FVC < 50%) Non-cardiovascular co-morbidity likely to cause death within 6 months (e.g. malignancy) Significant renal failure (estimated GFR < 30 ml/min/m2) Patient inability to provide informed consent (e.g. dementia)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HFpEF group<br>clinical or radiographic evidence of heart failure and left ventricular ejection fraction > 50% on transthoracic echocardiography | Diagnostic Test: MRI scan, Echo scan<br> <br> * Other names: cardiac MRI, trans thoracic echocardiography;|
| HFrEF group<br>Clinical or radiographic evidence of heart failure and left ventricular ejection fraction < 40% on transthoracic echocardiography | Diagnostic Test: MRI scan, Echo scan<br> <br> * Other names: cardiac MRI, trans thoracic echocardiography;|
| Healthy control group<br>Asymptomatic controls (age and sex-matched) without known heart disease | Diagnostic Test: MRI scan, Echo scan<br> <br> * Other names: cardiac MRI, trans thoracic echocardiography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite end-point of all-cause mortality or repeat hospitalisation with heart failure |  | Minimum 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of new clinical diagnoses detected by cardiac MRI |  | Through study completion, an average of 1 year | 
| Exercise capacity as assessed by the six-minute walk test |  | Through study completion, an average of 1 year | 
| Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire |  | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HFpEF, HFrEF