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

• ClinicalTrials.gov Identifier: NCT01581827
• Recruitment Status: Completed
• First Posted: April 20, 2012
• Last Update Posted: April 9, 2018
• Sponsor: Monash University
• Collaborator: National Health and Medical Research Council, Australia
• Information provided by (Responsible Party): Ingrid Hopper, Monash University

Tracking Information

• First Submitted Date: April 12, 2012
• First Posted Date: April 20, 2012
• Last Update Posted Date: April 9, 2018
• Study Start Date: January 2009
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2012)

• Change in NT-proBNP [ Time Frame: baseline and 5 years ]
• Change in echocardiogram [ Time Frame: baseline and 5 years ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: April 18, 2012): incidence of new heart failure [ Time Frame: baseline and 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study
• Official Title: SCREEN-HFL (SCReening Evaluation of the Evolution of New Heart Failure) - a Longitudinal Study

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Blood samples to measure BNP and NT-proBNP

• Sampling Method: Non-Probability Sample
• Study Population: People at high risk of heart failure
• Condition: Heart Failure
• Intervention: Not Provided

Study Groups/Cohorts

Study population

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

Publications *

• 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.
• 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. Erratum in: Open Heart. 2018 Sep 5;5(2):e000782corr1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 5, 2018): 3000
• Original Estimated Enrollment (submitted: April 18, 2012): 3500
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT01581827
• Other Study ID Numbers: 52/09
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ingrid Hopper, Monash University
• Study Sponsor: Monash University
• Collaborators: National Health and Medical Research Council, Australia

Investigators

• Principal Investigator: Henry Krum, MBBS FRACP PhD; Monash University/Alfred Hospital

• PRS Account: Monash University
• Verification Date: April 2018