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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

Tracking Information
First Submitted Date April 12, 2012
First Posted Date April 20, 2012
Last Update Posted Date April 9, 2018
Study Start Date January 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2012)
  • Change in NT-proBNP [ Time Frame: baseline and 5 years ]
  • Change in echocardiogram [ Time Frame: baseline and 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2012)
incidence of new heart failure [ Time Frame: baseline and 5 years ]
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 SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study
Official Title SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples to measure BNP and NT-proBNP
Sampling Method Non-Probability Sample
Study Population People at high risk of heart failure
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts Study population
People at high risk of heart failure (from SCREEN-HF study)
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: April 5, 2018)
3000
Original Estimated Enrollment
 (submitted: April 18, 2012)
3500
Actual Study Completion Date December 2017
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01581827
Other Study ID Numbers 52/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ingrid Hopper, Monash University
Study Sponsor Monash University
Collaborators National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University/Alfred Hospital
PRS Account Monash University
Verification Date April 2018