RecruitingPhase 4ACTRN12619001445167

Biomarker-guided Management Following a Heart Attack

Effect of cardiac biomarker (Nt-proBNP and high sensitivity troponin) guided risk management on clinical outcomes (all-cause mortality and cardiovascular readmission) in patients in the convalescent phase following Acute Coronary Syndromes: a Randomised, Controlled Trial


Sponsor

Professor Rob Doughty

Enrollment

1,028 participants

Start Date

Dec 2, 2019

Study Type

Interventional

Conditions

Summary

Patients who present with a heart attack are at risk of recurrent heart events in the next few years. A simple blood test can measure whether the heart is under stress. If this blood test is elevated then the potential is for specific medications to be used to reduce the risk of further heart events. The hypothesis is that a biomarker-guided approach to risk assessment and management will reduce the risk of recurrent clinical events for people following heart attacks. Patients will be those discharged from hospital following a heart attack within the last 1-12 months. Patients will be randomised (1:1) to either usual care group or to biomarker group. A stratified approach to patient management will be undertaken for the patients in the biomarker group, using heart biomarkers measured at the baseline visit. The “low biomarker” subgroup will be defined by NT-proBNP less than15pmol/L and hsTnT<99th centile; these patients will continue with follow up as per the usual care group. The “high biomarker” subgroup (NT-proBNP greater than 15pmol/L or NT-proBNP less than 15pmol/L with hsTnT greater than the 99th centile) will be seen for initiation/titration of ACE inhibitors/beta-blockers. Primary end point is the time to first event of death from any cause or cardiovascular readmission. The study will include 1770 patients at 3 centres in New Zealand, and follow up will be for 18 months.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After a heart attack, people are at ongoing risk of further cardiac events over the following months and years. A simple blood test can detect whether the heart is still under stress — elevated levels of certain proteins in the blood (called biomarkers) indicate that the heart muscle may be strained. This trial is testing whether using these biomarkers to guide treatment decisions — specifically, more aggressive medication adjustment — can reduce the risk of another heart attack or hospitalisation. Participants will be randomly assigned to either usual follow-up care or a biomarker-guided approach. In the biomarker group, blood tests will be used to identify which patients are at higher risk, and those patients will have their medications (such as ACE inhibitors and beta-blockers) more carefully adjusted to better protect their heart. The study will follow participants for 18 months and compare rates of death and cardiovascular re-admission between the two groups. You may be eligible if you are 18 or older, were discharged from hospital in the past 1 to 12 months after a heart attack (acute coronary syndrome), and are able to provide consent. People with known very poor heart pump function, severe valve disease, end-stage kidney disease, or a life-limiting illness are not eligible. This study is enrolling patients in New Zealand and offers a promising pathway to more personalised heart care.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

All patients will be seen between 1 and 12 months post hospital discharge for ACS, and have a baseline assessment. The patients will have NT-proBNP and high-sensitivity troponin measured, for those pa

All patients will be seen between 1 and 12 months post hospital discharge for ACS, and have a baseline assessment. The patients will have NT-proBNP and high-sensitivity troponin measured, for those patients in the intervention group if the NT-proBNP is greater than 15pmol/L or NT-proBNP less than 15pmol/L with hsTnT greater than the 99th centile then existing renin-angiotensin inhibitor and beta-blocker will be titrated to maximum tolerated dosages. No pre-specified specific individual drug will be used. The drugs to be titrated will be the medications that the patients were on when they were discharged from hospital. Example would be titration of cilazapril to 5mg/day or maximum tolerated dose and bisoprolol to 10mg/day or maximum tolerated dose (upper limits of these medications will not be exceeded) Maximum tolerated dosages will be determined by absence of symptoms such as postural dizziness for more than 2 weeks. Titration protocol will be to aim to double the dose of these medications every 2 weeks. Duration of the study for these medications is 24 months post-enrolment Adherence will be discussed with the patients at every visit but other specific strategies will not be utilised in this study.


Locations(1)

New Zealand

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ACTRN12619001445167


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