SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study (SHF-L)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
People at high risk of heart failure
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).
Contacts and Locations| Australia, Victoria | |
| Monash University | |
| Caulfield, Victoria, Australia, 3162 | |
| 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: | April 18, 2012 |
| 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 May 23, 2013