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

European Journal of Heart Failure

Volumn 5, Issue 3, 2003, Pages 295-303

  Cleland, J G F ^a   Freemantle, N ^b   Ball, S G ^c   Bonser, R S ^d   Camici, P ^e   Chattopadhyay, S ^a   Dutka, D ^f   Eastaugh, J ^b   Hampton, J ^l   Large, S ^g   Norell, M S ^h   Pennell, D J ⁱ   Pepper, J ⁱ   Sanda, S ^a   Senior, R ^j   Smith, D ^k  

^a CASTLE HILL HOSPITAL   (United Kingdom)

^b UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^c LEEDS GENERAL INFIRMARY   (United Kingdom)

^d QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^e HAMMERSMITH HOSPITAL   (United Kingdom)

^f ADDENBROOKE S HOSPITAL   (United Kingdom)

^g PAPWORTH HOSPITAL   (United Kingdom)

^h NEW CROSS HOSPITAL   (United Kingdom)

ⁱ ROYAL BROMPTON HOSPITAL   (United Kingdom)

^j NORTHWICK PARK HOSPITAL   (United Kingdom)

^k ROYAL DEVON AND EXETER HOSPITAL   (United Kingdom)

^l Royal Devon and Exeter Hospital ^*

more..

Author keywords

Heart failure; Heart study; Left ventricular systolic dysfunction; Revascularisation

Indexed keywords

ALDOSTERONE ANTAGONIST; ANTICOAGULANT AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; FUROSEMIDE; SPIRONOLACTONE;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY BYPASS GRAFT; CORONARY ARTERY DISEASE; DIAGNOSTIC IMAGING; FOLLOW UP; HEALTH ECONOMICS; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART LEFT VENTRICLE FAILURE; HEART MUSCLE ISCHEMIA; HEART MUSCLE REVASCULARIZATION; HUMAN; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; MYOCARDIAL HIBERNATION; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCREENING; STRESS ECHOCARDIOGRAPHY; SURVIVAL; SYMPTOMATOLOGY; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

CORONARY ARTERIOSCLEROSIS; FOLLOW-UP STUDIES; GREAT BRITAIN; HEART FAILURE, CONGESTIVE; HUMANS; MYOCARDIAL REVASCULARIZATION; RESEARCH DESIGN; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VENTRICULAR DYSFUNCTION, LEFT;

EID: 0012650167     PISSN: 13889842     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1388-9842(03)00056-4     Document Type: Article

References (40)

1. Cleland JGF, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, et al. for the Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology, Freemantle N, Eastaugh J, Mason J. The EuroHeart Failure Survey Programme: Survey on the Quality of Care Among Patients with Heart Failure in Europe. Part 1: Patient Characteristics and Diagnosis. Eur Heart J 2003;24:422-463.
2. Cleland JGF, Cohen-Solal A, Cosin-Aguilar J, Dietz R, Eastaugh J, Follath F, et al. For the IMPROVEMENT of Heart Failure Programme Committees and Investigators and the Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. An International Survey of the Management of Heart Failure in Primary Care. The IMPROVEMENT of Heart Failure Programme. Lancet 2002;360:1631-9.
3. Cleland J, Swedberg K, Cohen Solal A, Cosin-Aguilar J, Dietz R, Follath F, Gavazzi A, et al. for the Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology, Mason J, Freemantle N, Eastaugh J, for the Medicines Evaluation Group Centre for Health Economics UoY. The EuroHeart Failure Survey of the EUROHEART Survey Programme: A survey on the quality of care among patients with heart failure in Europe. Eur J Heart Fail 2000;2(2):123-132.
4. The Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. Increasing the awareness and improving the management of heart failure in Europe: the IMPROVEMENT of HF initiative. Eur J Heart Fail 1999;1:139-144.
5. Bax JJ, Wijns W, Cornel JH, Visser FC, Moersma E, Fioretti PM. Accuracy of currently available techniques for prediction of functional recovery after revascularisation in patients with left ventricular dysfunction due to chronic coronary artery disease: comparison of pooled data. J Am Col Cardiol 1997;30:1451-60.
6. Bax JJ, Van der Wall EE. Assessment of myocardial viability: guide to prognosis and clinical management. Eur Heart J 2000;21(12):981-91.
7. Cleland JGF, Pennell DJ, Ray S, Murray G, MacFarlane PW, Cowley A, et al. The CHRISTMAS study steering committee and investigators. The carvedilol hibernation reversible ischaemia trial: marker of success (CHRISTMAS). Eur J Heart Fail 1999;1:191-6.
8. Senior R, Kaul S, Lahiri A. Myocardial viability on echocardiography predicts long-term survival after revascularisation in patients with ischaemic congestive heart failure. J Am Coll Cardiol 1999;33(7):1848-54.
9. Pasquet A, Robert A, D'Hondt A-M, Dion R, Melin JA, Vanoverschelde J. Prognostic value of myocardial ischaemia and viability in patients with chronic left ventricular ischaemic dysfunction. Circulation 1999;100:141-8.
10. Senior R, Lahiri A. Dobutamine echocardiography predicts functional outcome after revascularisation in patients with dysfunctional myocardium irrespective of the perfusion pattern on resting thallium-201 imaging. Heart 1999;82:668-73.
11. Senior R, Glenville B, Basu S, Sridhara BS, Anagnostou E, Stanbridge R, et al. Dobutamine echocardiography and thallium-201 imaging predict functional improvement after revsacularisation in severe ischaemic left ventricular dysfunction. Br Heart J 1995;74:358-64.
12. Cleland JGF, Massie BM, Packer M. Sudden death in heart failure: vascular or electrical? Eur J Heart Fail 1999;1:41-5.
13. Cleland JGF, Thygesen K, Uretsky BF, Armstrong D, Horowitz JD, Massie BM, et al. Cardiovascular critical event pathways for the progression of heart failure. A report from the ATLAS study. Eur Heart J 2001;22:1601-12.
14. Uretsky B, Thygesen K, Armstrong PW, Cleland JGF, Horowitz JD, Massie BM, et al. Acute coronary findings at autopsy in heart failure patients with sudden death: Results from the assessment of treatment with lisinopril and survival study (ATLAS) trial. Circulation 2000;102:611-6.
15. Cleland JGF, Coletta AP, Nikitin N, Louis A, Clark A. Update of clinical trials from the American College of Cardiology 2003: EPHESUS, SPORTIF-III, ASCOT, COMPANION, UK-PACE, and T-Wave Alternans. Eur J Heart Fail 2003; in press.
16. Cleland JGF, Alamgir F, Nikitin N, Clark A, Norell M. What is the optimal medical management of ischaemic heart failure? Prog Cardiovasc Dis 2001;43(5):433-55.
17. Cleland JGF. Is aspirin 'The Weakest Link' in cardiovascular prophylaxis. The surprising lack of evidence supporting the use of aspirin for cardiovascular disease. Prog Cardiovasc Dis 2002;44:275-92.
18. Louis A, Cleland JGF, Crabbe S, Ford S, Thackray S, Houghton T, et al. Clinical trials update: CAPRICORN, COPERNICUS, MIRACLE, STAF, RITZ-2, RECOVER and RENAISSANCE and cachexia and cholesterol in heart failure. Highlights of the Scientific Sessions of the American College of Cardiology, Eur J Heart Fail 2001;2001(3):381-7.
19. Hunt SA, Baker DW, Chin MH, Cinquegrani MP, Feldmanmd AM, Francis GS, Ganiats TG, Goldstein S, Gregoratos G, Jessup ML, Noble J, Packer M, Silver MA, Warner-Stevenson L, (Committee Members), Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Jacobs AK, Hiratzka LF, Russell RO, Smith SCJ, (Task Force Members). ACC/AHA Guidelines for the Evaluation and Management of Chronic Heart Failure in the Adult: Executive Summary A Report of the American College of Cardiology/American heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). Circulation 2001;104(24):2996-3007.
20. Heart failure: management of patients with left ventricular systolic dysfunction. Agency for Health Care Policy and Research. Clin Pract Guidel Quick Ref Guide Clin 1994 Jun; (11):1-25.
21. Task Force for the Diagnosis and Treatment of Chronic Heart Failure ESoC. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J 2001;22:1527-1560.
22. Passamani E, Davis KB, Gillespie MJ, Killip T. and the CASS principal investigators and their associates. A randomised trial of coronary artery bypass surgery. Survival of patients with a low ejection fraction. N Engl J Med 1985;312:1665-71.
23. Alderman EL, Bourassa MG, Cohen LS, Davis KB, Kaiser GG, Killip T, et al. For the CASS investigators. Ten-year follow-up of survival and myocardial infarction in the randomized coronary artery surgery study. Circulation 1990;82:1629-46.
24. Sciagra R, Pellegri M, Pupi A, Bolognese L, Bisi G, Camovale V, et al. Prognostic implicatins of Tc-99m sestamibi viability imaging and subsequent therapeutic strategy in patients with chronic coronary artery disease and left ventricular dysfunction. J Am Coll Cardiol 2000;36(3):739-45.
25. Lewis ME, Townend JN, Davies P, Camici PG, Bonsel GJ. Coronary revascularisation for post-ischaemic heart failure: how myocardial viability affects survival. Heart 1999;82(6):684-8.
26. Afridi I, Grayburn PA, Panza JA, Zoghbi WA. Myocardial viability during dobutamine echocardiography predicts survival in patients with coronary artery disease and severe left ventricular systolic dysfunction. J Am Coll Cardiol 1998;32(4):921-6.
27. Senior R, Kaul S, Raval U, Lahiri A. Impact of revascularisation and myocardial viability determined by nitrate-enhanced Tc-99m sestamibi and Tl-201imaging on mortality and functional outcome in ischemic cardiomyopathy. J Nucl Cardiol 2002;9(5):454-62.
28. Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularisation on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol 2002;39:1151-8.
29. Coletta AP, Thackray S, Nikitin N, Cleland JGF. Clinical trials update: highlights of the scientific sessions of the American college of cardiology 2002: LIFE, DANAMI 2, MADIT-2, MIRACLE-ICD, OVERTURE, OCTAVE, ENABLE 1&2, CHRISTMAS, AFFIRM, RACE, WIZARD, AZACS, REMATCH, BNP trial and HARDBALL. Eur J Heart Fail 2002;4(3):381-8.
30. Pennell DJ, Ray SG, Davies G, Burgess M, Webster J, Slomka P, et al. The carvedilol hibernation reversible ischaemia trial: marker of success (CHRISTMAS) study: methodology of a randomised, placebo controlled, multicentre study of carvedilol in hibernation and heart failure. Int J Cardiol 2000;72(3):265-74.
31. Shih JH. Sample size calculation for complex clinical trials with survival endpoints. Controlled Clin Trials 1995;16:395-407.
32. RITA-2 trial participants. Coronary angioplasty vs. medical therapy for angina: the second randomised intervention treatment of angina (RITA-2) trial. Lancet 1997;350:461-468.
33. The TIME Investigators. Trial of invasive vs. medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): a randomised trial. Lancet 2001;358:951-957.
34. Hueb WA, Soares PR, de Oliveira SA, Arie S, Cardoso RHA, Wajsbrot DB, et al. Five-year follow-up of the medicine, angioplasty, or surgery study (mass). A prospective, randomized trial of medical therapy, balloon angioplasty, or bypass surgery for single proximal left anterior descending coronary artery stenosis. Circulation 2002;1999(suppl II):107-13.
35. Favarato D, Hueb WA, Gersh BJ, et al. Relative cost comparison among medical angioplasty and surgical revascularisation costs in MASS II study. Circulation 2002;106(19) (Suppl):II-678. (Abstract 3149).
36. Hampton JR. Coronary artery bypass grafting for the reduction of mortality: an analysis of the trials. Br Med J (Clin Res Ed) 1984;289(6453):1166-70.
37. The veterans administration coronary artery bypass surgery cooperative study group. Eleven-year survival in the veterans administration randomized trial of coronary bypass surgery for stable angina. N Engl J Med 1984;311(21):1333-1339.
38. Varnauskas E. European coronary surgery study group. Twelve-year follow-up of survival in the randomized European coronary surgery study. N Engl J Med 1988;319:332-7.
39. Pagano D, Lewis ME, Townend JN, Camici PG, Bonser RS. Coronary revascularisation for post-ischaemic heart failure: how myocardial viability affects survival. Heart 2000;83:456-61.
40. Wijns W, Vatner SF, Camici PG. Hibernating myocardium. N Engl J Med 1998;339:173-81.