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SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study (SHF-L)

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.
 
ClinicalTrials.gov Identifier: NCT01581827
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Ingrid Hopper, Monash University

Study Description
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Brief Summary:

Heart failure (when the heart does not pump as well as it used to) is a medical condition which reduces the quality of life for the sufferers. Approximately 10% of people in western societies aged over 75 develop heart failure. There has been a shift towards prevention of this disease and it is hoped that BNP (brain natriuretic peptides) and NT-proBNP (N-terminal proBNP) will prove to be useful indicators of those at greatest risk. The current study therefore plans to follow up the 3500 participants at risk of heart failure from the original SCREEN-HF study.

Participants who are willing to participate will be contacted annually. They will undergo a short physical exam, will be asked to complete a Quality of Life questionnaire and will have a blood sample taken. At the end of the study participants will also have an ECG and an echocardiogram.


Condition or disease
Heart Failure

Study Design
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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study
Study Start Date : January 2009
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
Study population
People at high risk of heart failure (from SCREEN-HF study)


Outcome Measures
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Primary Outcome Measures :
  1. Change in NT-proBNP [ Time Frame: baseline and 5 years ]
  2. Change in echocardiogram [ Time Frame: baseline and 5 years ]

Secondary Outcome Measures :
  1. incidence of new heart failure [ Time Frame: baseline and 5 years ]

Biospecimen Retention:   Samples Without DNA
Blood samples to measure BNP and NT-proBNP

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People at high risk of heart failure
Criteria

Inclusion Criteria:

  1. Consented and enrolled in the SCREEN-HF study and who agreed to further contact
  2. Age ≥ 60 years

  3. Subjects at high-risk of subsequent development of heart failure; comprising at least one of:

    • Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction
    • Current active ischaemic heart disease
    • Prior Cerebrovascular Accident (CVA)
    • Known valvular heart disease without known LV dysfunction
    • Atrial fibrillation
    • Treated hypertension, of at least 2 years duration
    • Treated Diabetes mellitus, of at least 2 years duration
    • Chronic renal impairment (eGFR < 60 ml/min)

Exclusion Criteria:

  1. Known systolic or diastolic heart failure
  2. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality (if known).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581827


Locations
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Australia, Victoria
Monash University
Caulfield, Victoria, Australia, 3162
Sponsors and Collaborators
Monash University
National Health and Medical Research Council, Australia
Investigators
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Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University/Alfred Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ingrid Hopper, Senior Lecturer, Monash University
ClinicalTrials.gov Identifier: NCT01581827    
Other Study ID Numbers: 52/09
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by Ingrid Hopper, Monash University:
Heart Failure
BNP
NT-proBNP
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases