Clinical trial NCT01581827: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
BNP
NT-proBNP
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2012-04-20
Enrollment: 3000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People at high risk of heart failure

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.


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).

Primary outcomes:
measure: Change in NT-proBNP
timeFrame: baseline and 5 years
measure: Change in echocardiogram
timeFrame: baseline and 5 years
Secondary outcomes:
measure: incidence of new heart failure
timeFrame: baseline and 5 years
Other outcomes:
Locations:
city: Caulfield
country: Australia
facility: Monash University
state: Victoria
Study officials:
affiliation: Monash University/Alfred Hospital
name: Henry Krum, MBBS FRACP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.