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Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)
This study is currently recruiting participants.
Study NCT00400257   Information provided by The Alfred
First Received: November 15, 2006   Last Updated: January 28, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

November 15, 2006
January 28, 2009
May 2007
 
 
Complete list of historical versions of study NCT00400257 on ClinicalTrials.gov Archive Site
 
 
 
Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)
SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure)

The investigators are hoping to identify early heart failure in patients who do not have symptoms as yet and at the same time assess the usefulness of Brain natriuetic peptide (BNP) in doing this.

Measuring Brain natriuetic peptide (BNP) can give us useful information about a persons heart function in patients with symptoms such as shortness of breath. This is because BNP levels rise when the heart is under pressure as it is in people with heart disease. However, we don't know if this is a useful test to do in people who are at a high risk of developing heart disease but who have no symptoms and have not been diagnosed with any heart problems. In this study we hope to recruit 3500 participants. This study is being run in conjunction with HBA and we estimate that 10,000 HBA members will need to be contact by letter and invited to screen for this study to achieve the required 3500.

Participants will undergo a routine blood test which will include measuring NTproBNP. Only participants in whom BNP is elevated will undergo additional blood tests (for cardiac markers), an ECG and echocardiography to determine if there is any indication that they do have heart disease even though they have not been diagnosed and are not symptomatic.

 
Observational
Cohort, Prospective
Heart Failure
Behavioral: Early detection of heart failure
People at high risk of heart failure.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
3500
August 2009
 

Inclusion Criteria:

  1. Age ≥60 years
  2. Have been insured with HBA for 12 months or longer
  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 ischemic heart disease
    • Prior Cerebrovascular Accident (CVA)
    • Known valvular heart disease without known LV dysfunction
    • Atrial fibrillation
    • Ventricular arrhythmia resulting in syncope or pre-syncope
    • Treated hypertension, of at least 2 years duration
    • Treated Diabetes mellitus, of at least 2 years duration
    • Estimated Glomerular Filtration Rate (eGFR) <50ml/min

Exclusion Criteria:

  1. Known systolic or diastolic heart failure
  2. Symptoms suggestive of current heart failure.
  3. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
  4. Medications for treatment of heart failure such as ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers or aldosterone antagonists.

Use of such medications for approved indications such as hypertension, post-MI management (without known LV dysfunction) or for diabetic nephropathy is permitted.

Both
60 Years and older
Yes
Contact: Henry Krum, Professor 61-3-9903-0042 henry.krum@med.monash.edu.au
Australia
 
 
NCT00400257
Bert Boffa, HBA
 
The Alfred
HBA
Principal Investigator: Henry Krum, Professor Monash University / Alfred Hospital
The Alfred
January 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.