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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400257
• Other study ID #: CP-04/06
• Status: Completed
• Phase: N/A
• First received: November 15, 2006
• Last updated: May 30, 2016
• Start date: May 2007
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Observational

Clinical Trial Summary

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 natriuretic peptide (BNP) in doing this.

Description:

Measuring Brain natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP)and can give us useful information about a persons heart function in patients with symptoms such as shortness of breath. This is because BNP/NT-proBNP 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 (recently renamed Bupa) and we estimate that 10,000 HBA members will need to be contacted by letter and invited to screen for this study to achieve the required 3500 (protocol amended to include people who meet the entry criteria but who are not insured through HBA).

This protocol has been amended to allow us to invite 50 participants with the lowest NT-proBNP levels to also continue in the study and have blood tests, an ECG and echocardiography as described below.

Participants will undergo a routine blood test which will include measuring NT-proBNP. Only participants in whom NT-proBNP 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: December 2015
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Age =60 years

2. Have been insured with HBA for 12 months or longer (Protocol amended to remove this criteria and allow enrollment of the general public)

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 (protocol amended to remove this entry criteria)

• 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. (protocol amended to remove this criteria)

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. (protocol amended to remove this criteria)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Early detection of heart failure
Early detection of heart failure

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Ingrid Hopper	HBA

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effectiveness of BNP in determining Heart Failure in people not previously diagnosed with the condition.		at visit 2	No