None listed
Conditions
Brief 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.
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 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
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.
Sponsors
Professor Rob Doughty
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary diagnosis of acute coronary syndrome Age > 18yrs
Exclusion criteria
Previously known left ventricular ejection fraction < 35%, severe aortic stenosis other life-limiting disease (life expectancy<1 year), end-stage renal disease (eGFR < 15mL/min) or inability to provide consent
Outcome results
None listed