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

Not Applicable

Completed

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615000044527
• Lead Sponsor: niversity of Otago, Christchurch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-21
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterize the dynamic range of new candidate markers on serial sampling during and after admission, treatment and discharge for Acute Decompensated Heart Failure (ADHF).[at admission, 24 hours, pre-discharge and at 7, 14 and 30 days post-discharge]

Secondary Outcome Measures

Name	Time	Method
Determine the temporal profile of plasma miR-652 in ADHF patients weekly for up to one month post-discharge[weekly for up to one month post-discharge.];determine if miR-652 predicts all causes of death in ADHF patients by data linkage to patient medical records to adjudicate cause of death[after two years of follow up.];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[after 2 years of follow up]