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

Sponsor
University of Leicester (Other)
Overall Status
Completed
CT.gov ID
NCT03050593
Collaborator
National Institute for Health Research, United Kingdom (Other)
280
Enrollment
26.9
Duration (Months)

Study Details

Study Description

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 Phase
  • 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)

Study Design

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 :
Feb 1, 2013
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm 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 Names:
  • 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 Names:
  • 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 Names:
  • cardiac MRI, trans thoracic echocardiography

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. The number of new clinical diagnoses detected by cardiac MRI [Through study completion, an average of 1 year]

    2. Exercise capacity as assessed by the six-minute walk test [Through study completion, an average of 1 year]

    3. Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire [Through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Leicester
    • National Institute for Health Research, United Kingdom

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Leicester
    ClinicalTrials.gov Identifier:
    NCT03050593
    Other Study ID Numbers:
    • 0328
    First Posted:
    Feb 13, 2017
    Last Update Posted:
    Feb 13, 2017
    Last Verified:
    May 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Heart Failure

    Study Results

    No Results Posted as of Feb 13, 2017