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A multicentre study to assess performance and optimal timing for blood sampling of recently discovered Heart Failure biomarkers for indication of prognosis.

A multicentre study to assess prognostic performance and optimal timing for sampling within the peri- and post-discharge period of recently discovered promising Heart Failure biomarkers for indication of 30, 90, 180 days and 1 year prognosis.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12615000044527
Acronym
TEMPORAL-HF (Timing of Emerging Markers with Prognostic potential for Optimising Regime ALgorithms
Enrollment
450
Registered
2015-01-21
Start date
2015-05-11
Completion date
2019-09-24
Last updated
2021-11-01

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

Conditions

None listed

Brief summary

Heart Failure is the leading of cause of hospitalisation in adults over 65 years. It is increasing in prevalence due to aging, rising rates of obesity and diabetes and enhanced long term survival with coronary heart disease (CHD) and hypertension. In New Zealand there over 12,000 HF admissions annually and, despite clinical advances, morbidity and mortality remain high. TEMPORALHF will assess prognostic performance (and optimal timing for sampling within the peri and post discharge period) of recently discovered promising HF biomarkers for indication of 30, 90, 180 days and 1 year prognosis. Results will be compared with NTproBNP as a preliminary step to assessing the applicability of the new markers in guiding acute and post discharge management of HF. Sampling will be conducted on consenting subjects fulfilling criteria for recruitment to attain a series of at least 300 patients with a clinical diagnosis of HF. All biomarkers will be compared with concurrent serial sampling for NTproBNP. Samples will be acquired at admission, 24 hours, pre discharge and at 7, 14 and 30 days post discharge. Events (all cause death, readmission for HF, admission for cardiovascular cause and all–cause readmission) will be recorded over two years of follow up.

Interventions

Sampling will be conducted on consenting subjects fulfilling criteria for recruitment to attain a series of at least 300 patients with a clinical diagnosis of HF. Analytes will include hs cTnT, GDF-15, ST2, MR-proANP, MR-proADM and galectin 3. All will be compared with concurrent serial sampling for NTproBNP. Samples will be acquired at admission, 24 hours, pre-discharge and at 7, 14 and 30 days post-discharge. Events (all-cause death, readmission for HF, admission for cardiovascular cause and a

Sampling will be conducted on consenting subjects fulfilling criteria for recruitment to attain a series of at least 300 patients with a clinical diagnosis of HF. Analytes will include hs cTnT, GDF-15, ST2, MR-proANP, MR-proADM and galectin 3. All will be compared with concurrent serial sampling for NTproBNP. Samples will be acquired at admission, 24 hours, pre-discharge and at 7, 14 and 30 days post-discharge. Events (all-cause death, readmission for HF, admission for cardiovascular cause and all–cause readmission) will be recorded over two years of follow-up.

Sponsors

University of Otago, Christchurch
Lead SponsorUniversity

Eligibility

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

Inclusion criteria

1. Patients aged >18 year, 2. Admitted with ADHF as evidenced by typical clinical features plus either radiological evidence of HF or an NTproBNP level >1000pg/ml (120 pmol/L).

Exclusion criteria

1. A primary diagnosis of either acute coronary syndrome (ACS), myocarditis/pericarditis, pericardial constriction or AF with rapid ventricular rate 2. Severe valvular disease requiring surgery, severe aortic stenosis (valve area <1 cm^2), or HF due to mitral stenosis 3. Under consideration for cardiac transplantation 4. Currently enrolled in other interventional or therapeutic heart failure trial. 5. Life expectancy due to non-cardiac disease of <6 months 6. Concurrent severe hepatic disease (determined by investigator) 7. Concurrent severe pulmonary disease (FEV1<1 L) 8. Severe renal impairment (plasma creatinine >250 micromol/L, EGFR < 15mls/min) or receiving renal replacement therapy. 9. Unwilling or unable to consent 10. Unable to comply with study protocol (e.g. out of town) 11. Pregnant, nursing or planning to be pregnant. 12. Is already enrolled in this study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026