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

University of Leicester280 enrolled

Overview

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.

Large scale prospective studies incorporating cardiac MRI, echocardiography and plasma sampling are currently lacking in HFpEF. The main aims of our study are to: 1. better phenotype and characterise HFpEF (also comparing with HFrEF and age- and sex- matched healthy controls) 2. provide mechanistic insights into pathophysiology 3. describe potential biomarkers and their relation to relevant clinical outcomes (exercise capacity, heart failure quality of life and prognosis)

Study Type

OBSERVATIONAL

Enrollment

280

Conditions

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

Interventions

MRI scan, Echo scanDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

The composite end-point of all-cause mortality or repeat hospitalisation with heart failure

Time frame: Minimum 6 month follow-up

Secondary Outcomes

The number of new clinical diagnoses detected by cardiac MRI

Time frame: Through study completion, an average of 1 year

Exercise capacity as assessed by the six-minute walk test

Time frame: Through study completion, an average of 1 year

Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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