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SIGNal peptides Indicative For Immediate Cardiac and Anti-pneumonic Treatment in acute Heart Failure

Evaluating the effectiveness of signal peptides in diagnosing pneumonia and heart failure in patients who present with acute shortness of breath.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000948695
Acronym
SIGNIFICANT-HF
Enrollment
902
Registered
2014-09-04
Start date
2007-07-20
Completion date
2030-12-31
Last updated
2025-10-27

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

Conditions

None listed

Brief summary

There is a pressing need for additional tools to help differentiate heart failure from other causes of dyspnea in acutely short of breath patients, and to improve our ability to provide accurate prognostic information and sound therapeutic management to heart failure patients. Where ADHF is the primary cause of dyspnoea, plasma BNP is a proven diagnostic adjunct. However, where pneumonia and ADHF co-exist, lack of specific pneumonic findings can delay appropriate introduction of antibiotic therapy. Misdiagnosis or delay in the introduction of appropriate therapy leads to significant morbidity and mortality from respiratory/circulatory failure and septicaemia. There is a need for biomarkers that can; 1) assist in the rapid diagnosis of pneumonia in ADHF, 2) assist in the prediction of who may be at risk of serious pneumonia-related complications and 3) aid the decision to administer antibiotic therapy where there is suspicion of pneumonia present in ADHF. The SIGNIFICANT-HF Study is an initiative to assess a new and unique biological markers in an acute shortness of breath population. 1200 people presenting to the Christchurch Hospital Emergency Department with non-traumatic shortness of breath will be invited to participate. 3 additional blood samples will be collected during admission for analysis of the levels of these newly identified heart hormones.

Interventions

We will recruit 2000 patients presenting to the Emergency Department (ED) of Christchurch Hospital with the primary complaint of breathlessness. Blood samples will be taken at presentation in the ED, at 24 hours and at discharge to test the diagnostic performance of Ghrelin signal peptide (GHRsp) and Neutrophil gelatinase associated lipocalin signal peptide (NGALsp) against and alongside N-terminal of the prohormone brain natriuretic peptide (NTproBNP) and procalcitonin (PCT) for the diagnosis

We will recruit 2000 patients presenting to the Emergency Department (ED) of Christchurch Hospital with the primary complaint of breathlessness. Blood samples will be taken at presentation in the ED, at 24 hours and at discharge to test the diagnostic performance of Ghrelin signal peptide (GHRsp) and Neutrophil gelatinase associated lipocalin signal peptide (NGALsp) against and alongside N-terminal of the prohormone brain natriuretic peptide (NTproBNP) and procalcitonin (PCT) for the diagnosis of pneumonia, HF and concurrent pneumonia and HF. Patients will be followed up at 30 and 90 days and 1 year to allow for assessment of prognostic power of GHRsp and NGALsp to predict subsequent events.All diagnoses will undergo standardised adjudication by two clinicians blinded to marker results.

Sponsors

Christchurch Heart Institute. University of Otago
Lead SponsorUniversity

Eligibility

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

Inclusion criteria

Eligible patients who report shortness of breath not due to trauma as their primary complaint upon presentation to the ED.

Exclusion criteria

Patients under 18 years of age or unable to provide consent are excluded. Patients with an acute ST-elevation myocardial infarction and patients on haemodialysis for renal failure are also excluded.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026