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NCT Number: NCT01581827

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monash University

Caulfield, Victoria, 3162, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Known systolic or diastolic heart failure
  • LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality (if known).

Treatment and study plan

Primary outcomes

  1. Change in NT-proBNP

    Time frame: baseline and 5 years

  2. Change in echocardiogram

    Time frame: baseline and 5 years

Secondary outcomes

  1. incidence of new heart failure

    Time frame: baseline and 5 years

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Acronym: SHF-L

Important dates

Study start
2009
Primary completion
2015
Study completion
2017
First posted
Apr 20, 2012
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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