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

Completed

• Conditions: Patients With Heart Failure With Reduced Ejection Fraction - HFrEF; Healthy Controls Group - Age and Sex-matched; Patients With Heart Failure and Preserved Ejection Fraction - HFpEF
• Interventions: Diagnostic Test: MRI scan, Echo scan

• Registration Number: NCT03050593
• Lead Sponsor: University of Leicester

Brief Summary

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

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 Timeline

• Study Start: 2013-02
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-08
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-13
• Last Update Posted: 2017-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HFrEF group	MRI scan, Echo scan	Clinical or radiographic evidence of heart failure and left ventricular ejection fraction \< 40% on transthoracic echocardiography
Healthy control group	MRI scan, Echo scan	Asymptomatic controls (age and sex-matched) without known heart disease
HFpEF group	MRI scan, Echo scan	clinical or radiographic evidence of heart failure and left ventricular ejection fraction \> 50% on transthoracic echocardiography

Primary Outcome Measures

Name	Time	Method
The composite end-point of all-cause mortality or repeat hospitalisation with heart failure	Minimum 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire	Through study completion, an average of 1 year
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