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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03050593
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
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 Diagnostic Test: MRI scan, Echo scan

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)

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Study Type : Observational
Actual Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction
Study Start Date : February 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
HFpEF group
clinical or radiographic evidence of heart failure and left ventricular ejection fraction > 50% on transthoracic echocardiography
Diagnostic Test: MRI scan, Echo scan
Other Name: cardiac MRI, trans thoracic echocardiography

HFrEF group
Clinical or radiographic evidence of heart failure and left ventricular ejection fraction < 40% on transthoracic echocardiography
Diagnostic Test: MRI scan, Echo scan
Other Name: cardiac MRI, trans thoracic echocardiography

Healthy control group
Asymptomatic controls (age and sex-matched) without known heart disease
Diagnostic Test: MRI scan, Echo scan
Other Name: cardiac MRI, trans thoracic echocardiography

Primary Outcome Measures :
  1. The composite end-point of all-cause mortality or repeat hospitalisation with heart failure [ Time Frame: Minimum 6 month follow-up ]

Secondary Outcome Measures :
  1. The number of new clinical diagnoses detected by cardiac MRI [ Time Frame: Through study completion, an average of 1 year ]
  2. Exercise capacity as assessed by the six-minute walk test [ Time Frame: Through study completion, an average of 1 year ]
  3. Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire [ Time Frame: Through study completion, an average of 1 year ]

Biospecimen Retention:   Samples With DNA
EDTA Plasma, serum, urine, DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects with heart failure from Hospital (including ward patients and out-patients clinic)

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)
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: University of Leicester Identifier: NCT03050593    
Other Study ID Numbers: 0328
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: May 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Leicester:
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases