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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03050593
Acronym
DIAMONDHFpEF
Enrollment
280
Registered
2017-02-13
Start date
2013-02-28
Completion date
2015-05-31
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

HFpEF, HFrEF

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)

Interventions

DIAGNOSTIC_TESTMRI scan, Echo scan

Sponsors

National Institute for Health Research, United Kingdom
CollaboratorOTHER_GOV
University of Leicester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
The composite end-point of all-cause mortality or repeat hospitalisation with heart failureMinimum 6 month follow-up

Secondary

MeasureTime frame
The number of new clinical diagnoses detected by cardiac MRIThrough study completion, an average of 1 year
Exercise capacity as assessed by the six-minute walk testThrough study completion, an average of 1 year
Quality of life assessed by the Minnesota Living with Heart Failure QuestionnaireThrough study completion, an average of 1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026