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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier:
NCT01581827
First received: April 12, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • Change in NT-proBNP [ Time Frame: baseline and 5 years ] [ Designated as safety issue: No ]
  • Change in echocardiogram [ Time Frame: baseline and 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of new heart failure [ Time Frame: baseline and 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples to measure BNP and NT-proBNP


Estimated Enrollment: 3500
Study Start Date: January 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Study population
People at high risk of heart failure (from SCREEN-HF study)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01581827

Locations
Australia, Victoria
Monash University
Caulfield, Victoria, Australia, 3162
Sponsors and Collaborators
Monash University
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Henry Krum, MBBS FRACP PhD Monash University/Alfred Hospital
  More Information

No publications provided

Responsible Party: Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier: NCT01581827     History of Changes
Other Study ID Numbers: 52/09
Study First Received: April 12, 2012
Last Updated: May 29, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Monash University:
Heart Failure
BNP
NT-proBNP

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014