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

Completed

• Conditions: Heart Failure

• Registration Number: NCT01581827
• Lead Sponsor: Monash University

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 available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-18
• Study First Posted: 2012-04-20
• Primary Completion: 2015-12
• Study Completion: 2017-12
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in NT-proBNP	baseline and 5 years
Change in echocardiogram	baseline and 5 years

Secondary Outcome Measures

Name	Time	Method
incidence of new heart failure	baseline and 5 years

Trial Locations

Locations (1)

Monash University; 🇦🇺 Caulfield, Victoria, Australia