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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

Tracking Information
First Submitted Date February 6, 2017
First Posted Date February 13, 2017
Last Update Posted Date February 13, 2017
Study Start Date February 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2017)
The composite end-point of all-cause mortality or repeat hospitalisation with heart failure [ Time Frame: Minimum 6 month follow-up ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 8, 2017)
  • The number of new clinical diagnoses detected by cardiac MRI [ Time Frame: Through study completion, an average of 1 year ]
  • Exercise capacity as assessed by the six-minute walk test [ Time Frame: Through study completion, an average of 1 year ]
  • Quality of life assessed by the Minnesota Living with Heart Failure Questionnaire [ Time Frame: Through study completion, an average of 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Developing Imaging And plasMa biOmarkers iN Describing Heart Failure With Preserved Ejection Fraction (DIAMONDHFpEF)
Official Title Prospective, Observational, Single-centre, Cohort Study Aimed at Developing Imaging and Plasma Biomarkers in Heart Failure With Preserved Ejection Fraction
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
EDTA Plasma, serum, urine, DNA
Sampling Method Probability Sample
Study Population Subjects with heart failure from Hospital (including ward patients and out-patients clinic)
Condition
  • 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
Intervention Diagnostic Test: MRI scan, Echo scan
Other Name: cardiac MRI, trans thoracic echocardiography
Study Groups/Cohorts
  • HFpEF group
    clinical or radiographic evidence of heart failure and left ventricular ejection fraction > 50% on transthoracic echocardiography
    Intervention: Diagnostic Test: MRI scan, Echo scan
  • HFrEF group
    Clinical or radiographic evidence of heart failure and left ventricular ejection fraction < 40% on transthoracic echocardiography
    Intervention: Diagnostic Test: MRI scan, Echo scan
  • Healthy control group
    Asymptomatic controls (age and sex-matched) without known heart disease
    Intervention: Diagnostic Test: MRI scan, Echo scan
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 8, 2017)
280
Original Actual Enrollment Same as current
Actual Study Completion Date May 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03050593
Other Study ID Numbers 0328
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Leicester
Study Sponsor University of Leicester
Collaborators National Institute for Health Research, United Kingdom
Investigators Not Provided
PRS Account University of Leicester
Verification Date May 2015