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

NCT ID: NCT00400257

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2015-12-31

Brief 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.

Detailed 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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

People at high risk of heart failure.

Early detection of heart failure

Intervention Type: BEHAVIORAL

Early detection of heart failure

Interventions

Early detection of heart failure

Early detection of heart failure

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HBA

UNKNOWN

Sponsor Role: collaborator

Ingrid Hopper

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Hopper

Dr Ingrid Hopper

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Henry Krum, Professor

Role: PRINCIPAL_INVESTIGATOR

Monash University / Alfred Hospital

Locations

Alfred Hospital

Melbourne, Victoria, Australia

Countries

Australia

References

Campbell DJ, Coller JM, Gong FF, McGrady M, Boffa U, Shiel L, Liew D, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL. Kidney age - chronological age difference (KCD) score provides an age-adapted measure of kidney function. BMC Nephrol. 2021 Apr 26;22(1):152. doi: 10.1186/s12882-021-02324-y.

Reference Type: DERIVED

PMID: 33902478 (View on PubMed)

Gong FF, Jelinek MV, Castro JM, Coller JM, McGrady M, Boffa U, Shiel L, Liew D, Wolfe R, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL, Campbell DJ. Risk factors for incident heart failure with preserved or reduced ejection fraction, and valvular heart failure, in a community-based cohort. Open Heart. 2018 Jul 23;5(2):e000782. doi: 10.1136/openhrt-2018-000782. eCollection 2018.

Reference Type: DERIVED

PMID: 30057766 (View on PubMed)

Other Identifiers

CP-04/06

Identifier Type: -

Identifier Source: org_study_id