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

University of Leicester

Status: Completed

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

Treatments: Diagnostic Test: MRI scan, Echo scan

Study type: Observational

Funder types: Other

Identifiers

NCT03050593

0328

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

280 participants in 3 patient groups

HFpEF group

Description:

clinical or radiographic evidence of heart failure and left ventricular ejection fraction \> 50% on transthoracic echocardiography

Treatment:

Diagnostic Test: MRI scan, Echo scan

HFrEF group

Description:

Clinical or radiographic evidence of heart failure and left ventricular ejection fraction \< 40% on transthoracic echocardiography

Treatment:

Diagnostic Test: MRI scan, Echo scan

Healthy control group

Description:

Asymptomatic controls (age and sex-matched) without known heart disease

Treatment:

Diagnostic Test: MRI scan, Echo scan