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

Heart Failure Clinical Trial

— SHF-L  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01581827
• Other study ID #: 52/09
• Status: Completed
• First received: April 12, 2012
• Last updated: April 5, 2018
• Start date: January 2009
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Australia	Monash University	Caulfield	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in NT-proBNP		baseline and 5 years
Primary	Change in echocardiogram		baseline and 5 years
Secondary	incidence of new heart failure		baseline and 5 years