NCT00400257

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

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

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

2.7 years

First QC Date

November 15, 2006

Last Update Submit

May 30, 2016

Conditions

Heart Failure

Keywords

Heart FailureBNP

Outcome Measures

Primary Outcomes (1)

  • To assess the effectiveness of BNP in determining Heart Failure in people not previously diagnosed with the condition.

    at visit 2

Study Arms (1)

1

People at high risk of heart failure.

Behavioral: Early detection of heart failure

Interventions

Early detection of heart failureBEHAVIORAL

Early detection of heart failure

1

Eligibility Criteria

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

People at high risk of heart failure.

You may qualify if:

  • Age ≥60 years
  • Have been insured with HBA for 12 months or longer (Protocol amended to remove this criteria and allow enrollment of the general public)
  • 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

You may not qualify if:

  • Known systolic or diastolic heart failure
  • Symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
  • LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, 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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Henry Krum, Professor

    Monash University / Alfred Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Ingrid Hopper

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

May 1, 2007

Primary Completion

January 1, 2010

Study Completion

December 1, 2015

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

AU(1)