The heart failure revascularisation trial (HEART): rationale, design and methodology

Abstract

Background: Most patients with heart failure due to left ventricular systolic dysfunction (LVSD) secondary to coronary artery disease (CAD) have evidence of myocardium in jeopardy (reversible ischaemia andyor stunning hibernation). It is not known whether revascularisation in such cases is safe or beneficial. Aims: To determine whether revascularisation will improve the survival of patients with LVSD and heart failure secondary to CAD and myocardium in jeopardy. Methods: This is a randomised controlled trial comparing revascularisation or not, in addition to optimal medical therapy with ACE inhibitors, beta-blockers, aldosterone antagonists and an anti-thrombotic agent. Patients must have heart failure requiring treatment with diuretics, a left ventricular ejection fraction -35% and evidence of coronary disease. Myocardial viability and ischaemia are assessed by a broad range of techniques including stress echocardiography and nuclear imaging. All imaging tests are reviewed in core laboratories to ensure uniform reporting. Any conventional revascularisation technique is permitted. The primary outcome measure is all cause mortality. Symptoms, quality of life and health economic issues will also be explored. Assuming an annual mortality of 10% in the control group and allowing for substantial cross-over rates, a study of 800 patients followed for 5 years has 80% power with an alpha of 0.05 (two-sided) to show a 25% reduction in mortality with revascularisation. Results: At the time of writing 180 patients have been screened for inclusion, 111 have consented to participate and 70 have been randomised. The results of viability testing are awaited in 22 patients. Twenty-six patients had been investigated for myocardial viability andyor by angiography prior to consent, as part of the routine practice in that cardiology department. Of 68 patients who have completed assessment only after consent, 47 (69%) were included. The principal reason for drop-out between consent and randomisation was lack of evidence of myocardial ischaemia or hibernation. Conclusion: The HEART trial will help to determine whether investigation of myocardial ischaemia andyor viability with a view to revascularisation should become part of the routine care of patients with heart failure due to LVSD and CAD.

Noninvasive assessment myocardial viability: Current status and future directions

“…The UK HEART trial 137,138 illustrates the problem of lower than anticipated patient enrollment. This investigator-initiated study was funded by the Medical Research Council of the United Kingdom.…”

Atualização da Diretriz Brasileira de Insuficiência Cardíaca Crônica - 2012

“…Metanálise demonstrou que a revascularização pode ser realizada em pacientes com disfunção ventricular com aceitável mortalidade em torno de 5% 161 . Entretanto, pode haver substrato heterogêneo consistindo da mistura de fibrose, músculo atordoado, hibernado e remodelado em várias proporções nos pacientes com miocardiopatia isquêmica 162 . Além desse estudo ter recebido sérias críticas, seu resultado poderia ser considerado neutro caso utilizássemos métodos estatísticos atuais, foi realizado sem a otimização da medicação para insuficiência cardíaca disponível atualmente, que pode tanto melhorar o músculo atordoado/hibernado como o remodelado 163 .…”

Ischemic cardiomyopathy: possibilities of surgical treatment

“…the Surgical Treatment for Ischemic Heart Disease -STICH trial) (4), revaskulizacijos, sergant ŠN, tyrimą (angl. Heart Failure Revascularization -HEART trial) (25) ir pozitroninės emisijos tomografijos ir sveikimo po revaskulizacijos antrąjį tyrimą (angl. the PET and Recovery Following Revascularization-2 -PARR-2 trial) (26).…”