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

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ClinicalTrials.gov Identifier: NCT03050593
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
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)
Criteria

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 ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03050593     History of Changes
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:
HFpEF
HFrEF
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases