SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure) - Full Text View

Sponsors and Collaborators:	The Alfred HBA
Information provided by:	The Alfred
ClinicalTrials.gov Identifier:	NCT00400257

Purpose

We 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.

Condition	Intervention
Heart Failure	Behavioral: Early detection of heart failure

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure)

Further study details as provided by The Alfred:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Blood samples

Estimated Enrollment:	3500
Study Start Date:	May 2007
Estimated Study Completion Date:	August 2008

Groups/Cohorts	Assigned Interventions
1 People at high risk of heart failure.	Behavioral: Early detection of heart failure Early detection of heart failure

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

People at high risk of heart failure.

Criteria

Inclusion Criteria:

Age ≥60 years
Have been insured with HBA for 12 months or longer
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:

Known systolic or diastolic heart failure
Symptoms suggestive of current heart failure.
LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400257

Contacts

Contact: Henry Krum, Professor

61-3-9903-0042

henry.krum@med.monash.edu.au

Locations

Australia, Victoria
Alfred Hospital	Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Henry Krum, Professor 61-3-9903-0042 henry.krum@med.monash.edu.au
Principal Investigator: Henry Krum, Professor
Sub-Investigator: Chris Reid, A/Professor
Sub-Investigator: Danny Liew, Dr

Sponsors and Collaborators

The Alfred

HBA

Investigators

Principal Investigator:

Henry Krum, Professor

Monash University / Alfred Hospital

More Information

Responsible Party:	HBA ( Bert Boffa )
Study ID Numbers:	CP-04/06
Study First Received:	November 15, 2006
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00400257
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The Alfred:

Heart Failure
BNP

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009