NCT01581827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

6.9 years

First QC Date

April 12, 2012

Last Update Submit

April 5, 2018

Conditions

Heart Failure

Keywords

Heart FailureBNPNT-proBNP

Outcome Measures

Primary Outcomes (2)

  • Change in NT-proBNP

    baseline and 5 years

  • Change in echocardiogram

    baseline and 5 years

Secondary Outcomes (1)

  • incidence of new heart failure

    baseline and 5 years

Study Arms (1)

Study population

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

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People at high risk of heart failure

You may qualify if:

  • Consented and enrolled in the SCREEN-HF study and who agreed to further contact
  • Age ≥ 60 years
  • 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)

You may not qualify if:

  • Known systolic or diastolic heart failure
  • LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality (if known).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monash University

Caulfield, Victoria, 3162, Australia

Location

Related Publications (2)

  • 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.

    PMID: 33902478DERIVED

  • 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.

    PMID: 30057766DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to measure BNP and NT-proBNP

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Henry Krum, MBBS FRACP PhD

    Monash University/Alfred Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 20, 2012

Study Start

January 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

April 9, 2018

Record last verified: 2018-04

Locations

AU(1)