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The PRO-BNP Evaluation (PROBE) Study

Do Plasma Pro-BNP Levels Measured Prior to Discharge Alter Management and Outcomes in Patients Admitted with Heart Failure? A Randomised Controlled Trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12605000733673
Acronym
PROBE
Enrollment
58
Registered
2005-11-11
Start date
2004-06-01
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Three hundred (300) patients admitted to hospital with clinical heart failure as a primary diagnosis and not enrolled in other studies will be eligible for inclusion. Eligible patients will be approached at day 4 of admission to hospital, once initial stabilisation has occurred and prior to hospital discharge. If written informed consent is obtained the patients will provide a blood sample for proBNP levels. Patients will then be randomised to BNP or no-BNP groups. For the BNP group, the proBNP result will be given to the physician responsible for the patient’s care prior to discharge. The report with proBNP result will include an interpretative statement based on the known prognostic value of BNP levels to predict rehospitalisation and death from heart failure. For the No-BNP group, proBNP levels will not be given to the physician responsible for the patient’s care. Clinical follow-up will then be collected on all patients by phone call to patient, physician and GP at 180 and 360 days. Mortality data will be confirmed from the Births, Deaths and Marriages register. Hospitalisation will be confirmed from the Patient Management System and clinical record.

Interventions

Patients randomised to BNP group. For the BNP group, the proBNP result will be given to the physician responsible for the patient's care prior to discharge. The report with proBNP result will include an interpretative statement based on the known prognostic value of BNP levels to predict rehospitalisation and death from heart failure. Three hundred (300) patients admitted to hospital with clinical heart failure as a primary diagnosis and not enrolled in other studies will be eligible for inclu

Patients randomised to BNP group. For the BNP group, the proBNP result will be given to the physician responsible for the patient's care prior to discharge. The report with proBNP result will include an interpretative statement based on the known prognostic value of BNP levels to predict rehospitalisation and death from heart failure. Three hundred (300) patients admitted to hospital with clinical heart failure as a primary diagnosis and not enrolled in other studies will be eligible for inclusion. Eligible patients will be approached at day 4 of admission to hospital, once initial stabilisation has occurred and prior to hospital discharge. If written informed consent is obtained the patients will provide a blood sample for proBNP levels. Clinical follow-up will then be collected on all patients by phone call to patient, physician and GP at 180 and 360 days. Mortality data will be confirmed from the Births, Deaths and Marriages register. Hospitalisation will be confirmed from the Patient Management System and clinical record.

Sponsors

Roche
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Admitted with clinical heart failure (Framingham criteria).

Exclusion criteria

Unable to consent- Enrolment in other trials- Not residing locally- Acute coronary syndrome, if LVEF is >40% and/or the patient is revascularised- Severe stenotic valvular disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026