Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000044527
Ethics application status
Approved
Date submitted
23/12/2014
Date registered
21/01/2015
Date last updated
28/10/2021
Date data sharing statement initially provided
26/04/2019
Date results information initially provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A multicentre study to assess performance and optimal timing for blood sampling of recently discovered Heart Failure biomarkers for indication of prognosis.
Scientific title
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.
Secondary ID [1] 285890 0
nil known
Universal Trial Number (UTN)
Trial acronym
TEMPORAL-HF

(Timing of Emerging Markers with Prognostic potential for Optimising Regime ALgorithms in Heart Failure)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 293813 0
Condition category
Condition code
Cardiovascular 294114 294114 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 290872 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293912 0
Characterize the dynamic range of new candidate markers on serial sampling during and after admission, treatment and discharge for Acute Decompensated Heart Failure (ADHF).
Timepoint [1] 293912 0
at admission, 24 hours, pre-discharge and at 7, 14 and 30 days post-discharge
Secondary outcome [1] 312141 0
Determine the temporal profile of plasma miR-652 in ADHF patients weekly for up to one month post-discharge
Timepoint [1] 312141 0
weekly for up to one month post-discharge.
Secondary outcome [2] 312275 0
determine if miR-652 predicts all causes of death in ADHF patients by data linkage to patient medical records to adjudicate cause of death
Timepoint [2] 312275 0
after two years of follow up.
Secondary outcome [3] 312276 0
determine if miR-652 predicts all–cause readmission to hospital in ADHF patients by data linkage to patient medical records to adjudicate readmission discharge diagnoses
Timepoint [3] 312276 0
after 2 years of follow up

Eligibility
Key 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).
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
A sample size of 300 patients with ADHF will ensure a minimum of 100 deaths and over 200 readmissions for recurrent ADHF over 2 years follow-up and will allow robust testing of multi-variate predictive models including 10 or more clinical, imaging variables and candidate markers as putative independent predictive markers of the nominated outcomes of interest. The majority of analyses undertaken for this study are considered hypothesis generating. Consistent patterns of prediction and association will be identified for subsequent validation in other patient cohorts

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2015
Actual
11/05/2015
Date of last participant enrolment
Anticipated
1/10/2019
Actual
24/09/2019
Date of last data collection
Anticipated
Actual
25/03/2021
Sample size
Target
450
Accrual to date
Final
450
Recruitment outside Australia
Country [1] 6567 0
New Zealand
State/province [1] 6567 0
Christchurch
Country [2] 6592 0
New Zealand
State/province [2] 6592 0
Auckland

Funding & Sponsors
Funding source category [1] 290473 0
Government body
Name [1] 290473 0
Health Research Council of New Zealand
Country [1] 290473 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
2 Riccarton Avenue
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 289175 0
Charities/Societies/Foundations
Name [1] 289175 0
Christchurch Heart Institute
Address [1] 289175 0
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011
Country [1] 289175 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292142 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 292142 0
1 The Terrace
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 292142 0
New Zealand
Date submitted for ethics approval [1] 292142 0
18/12/2014
Approval date [1] 292142 0
17/02/2015
Ethics approval number [1] 292142 0
14/CEN/222

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53710 0
Prof Mark Richards
Address 53710 0
Department of Medicine
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011
Country 53710 0
New Zealand
Phone 53710 0
+643 364 1063
Fax 53710 0
+643 364 1115
Email 53710 0
[email protected]
Contact person for public queries
Name 53711 0
Ms Lorraine Skelton
Address 53711 0
Department of Medicine
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011
Country 53711 0
New Zealand
Phone 53711 0
+643 364 1063
Fax 53711 0
+643 364 1115
Email 53711 0
[email protected]
Contact person for scientific queries
Name 53712 0
Prof Mark Richards
Address 53712 0
Department of Medicine
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011
Country 53712 0
New Zealand
Phone 53712 0
+643 364 1063
Fax 53712 0
+643 364 1115
Email 53712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.