SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

NCT ID: NCT01581827

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

Conditions

Heart Failure

Study Design

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

Study Groups

Study population

People at high risk of heart failure (from SCREEN-HF study)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Consented and enrolled in the SCREEN-HF study and who agreed to further contact

2. Age ≥ 60 years

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 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

1. Known systolic or diastolic heart failure

2. LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality (if known).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health and Medical Research Council, Australia

OTHER

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Hopper

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henry Krum, MBBS FRACP PhD

Role: PRINCIPAL_INVESTIGATOR

Monash University/Alfred Hospital

Locations

Monash University

Caulfield, 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

52/09

Identifier Type: -

Identifier Source: org_study_id