End points in pulmonary arterial hypertension: The way forward

European Respiratory Journal

Volumn 23, Issue 6, 2004, Pages 947-953

  Peacock, A ^a   Naeije, R ^b   Galie N ^c   Reeves, J T ^d  

^a WESTERN INFIRMARY   (United Kingdom)

^b ERASME HOSPITAL   (Belgium)

^c UNIVERSITY OF BOLOGNA   (Italy)

^d UNIVERSITY OF COLORADO HOSPITAL   (United States)

Author keywords

Biological markers; Exercise physiology; Haemodynamics; Imaging; Pulmonary hypertension; Quality of life

Indexed keywords

BIOLOGICAL MARKER; BOSENTAN; ENDOTHELIN RECEPTOR ANTAGONIST; ILOPROST; PHOSPHODIESTERASE V INHIBITOR; PLACEBO; PROSTACYCLIN; PROSTACYCLIN DERIVATIVE; UNIPROST;

ARTICLE; CARDIOVASCULAR SYSTEM; CLINICAL TRIAL; DIAGNOSTIC IMAGING; DISEASE SEVERITY; EXERCISE; EXPERIMENTAL DESIGN; FUTUROLOGY; HEMODYNAMICS; HUMAN; LICENSING; PRIORITY JOURNAL; PROGNOSIS; PULMONARY HYPERTENSION; QUALITY OF LIFE; WALKING;

EID: 3042595558     PISSN: 09031936     EISSN: None     Source Type: Journal    
DOI: 10.1183/09031936.04.00122204     Document Type: Article

References (77)

1. Rich S, Kauffmann E, Levy PS. The effects of high doses of calcium channel blockers on survival in primary pulmonary hypertension. N Engl J Med 1992; 327: 76-81.
2. Barst RJ, Rubin LJ, Long WA, et al. A comparison of continuous intravenous epoprostenol (prostacyclin) with conventional therapy for primary pulmonary hypertension. N Engl J Med 1996; 334: 296-302.
3. Simonneau G, Barst RJ, Galie N, et al. Continuous subcutaneous infusion of teprostinil, an epoprostenol analogue, in patients with pulmonary arterial hypertension: a double-blind randomised controlled trial. Am J Respir Crit Care Med 2002; 165: 800-804.
4. Galie N, Humbert M, Vachiery JL, et al. Effect of beraprost sodium, an oral epoprostenol analogue, in patients with pulmonary arterial hypertension: a randomised double-blind, placebo-controlled trial. J Am Coll Cardiol 2002; 39: 1496-1502.
5. Olscheswki H, Simonneau G, Galie N, et al. Inhaled iloprost for severe pulmonary hypertension. New Engl J Med 2002; 347: 1119-1123.
6. Rubin RJ, Badesch DB, Barst RJ, et al. Bosentan in patients with pulmonary artery hypertension: a randomised placebo controlled, multicentre study. N Engl J Med 2002; 346: 896-903.
7. Galie N. Do we need controlled clinical trials in pulmonary arterial hypertension? Eur Respir J 2001; 17: 1-3.
8. Galie N, Manes A, Branzi A. The new clinical trials on pharmacological treatment in pulmonary arterial hypertension. Eur Respir J 2002; 20: 1037-1049.
9. D'Alonzo GE, Barst RJ, Ayres SM, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med 1991; 115: 343-349.
10. Raymond RJ, Hinderliter AL, Willis PW, et al. Echocardiographic predictors of adverse outcomes in primary pulmonary hypertension, J Am Coll Cardiol 2002; 39: 1214-1219.
11. Hinderliter AL, Willis PW, Barst RJ, et al. Effects of long-term infusion of prostacyclin (epoprostenol) on echocardiographic measures of right ventricular structure and function in primary pulmonary hypertension. Circulation 1997; 95: 1479-1486.
12. Galie N, Hinderliter AL, Torbicki A, et al. Effects of the oral endothelin-receptor antagonist bosentan on echocardiographic and Doppler measures in patients with pulmonary arterial hypertension. J Am Coll Cardiol 2003; 41: 1380-1386.
13. Saba TS, Foster J, Cockburn M, Cowan M, Peacock AJ. Ventricular mass index using magnetic resonance imaging accurately estimates pulmonary artery pressure. Eur Respir J 2002; 20: 1519-1524.
14. Apfel HD, Shen Z, Gopal AS, et al. Quantitative three dimensional echocardiography in patients with pulmonary hypertension and compressed left ventricles: comparison with cross sectional echocardiography and magnetic resonance imaging. Heart 1996; 76: 350-354.
15. Boxt LM, Katz J, Kolb T, Czegledy FP, Barst RJ. Direct quantitation of right and left ventricular volumes with nuclear magnetic resonance imaging in patients with primary pulmonary hypertension. J Am Coll Cardiol 1992; 19: 1508-1515.
16. Bellenger NG, Grothues F, Smith GC, Pennell DJ. Quantification of right and left ventricular function by cardiovascular magnetic resonance. Herz 2000; 25: 392-399.
17. Markiewicz W, Sechtem U, Higgins CB. Evaluation of the right ventricle by magnetic resonance imaging. Am Heart J 1987; 113: 8-15.
18. Hinderliter AL, Willis PW, Long W, et al. Frequency and prognostic significance of pericardial effusion in primary pulmonary hypertension. Am J Cardiol 1999; 84: 481-484, A10.
19. Mcluzin J, Spinarova L, Bakala J, et al. Pulsed Doppler tissue imaging of the velocity of tricuspid annular systolic motion: a new, rapid, and non-invasive method of evaluating right ventricular systolic function. Eur Heart J 2001; 22: 340-348.
20. Naeije R, Torbicki A. More on the noninvasive diagnosis of pulmonary hypertension: Doppler echocardiography revisited. Eur Respir J 1995: 8: 1445-1449.
21. Nootens M, Wolfkiel CJ, Chomka EV, Rich S. Understanding right and left ventricular systolic function and interactions at rest and with exercise in primary pulmonary hypertension. Am J Cardiol 1995; 75: 374-377.
22. Tei C, Dujardin KS, Hodge DO, et al. Doppler echocardiographic index for assessment of global right ventricular function, J Am Soc Echocardiogr 1996; 9: 838-847.
23. Vogel M, Schmidt MR, Kristiansen SB, et al. Validation of myocardial acceleration during isovolumic contraction as a novel noninvasive index of right ventricular contractility: comparison with ventricular pressure-volume relations in an animal model. Circulation 2002; 105: 1693-1699.
24. Yeo TC, Dujardin KS, Tei C, Mahoney DW, McGoon MD, Seward JB. Value of a Doppler-derived index combining systolic and diastolic time intervals in predicting outcome in primary pulmonary hypertension. Am J Cardiol 1998; 81: 1157-1161.
25. Eysmann SB, Palevsky HI, Reichek N, Hackney K, Douglas PS. Two-dimensional and Doppler-echocardiographic and cardiac catheterization correlates of survival in primary pulmonary hypertension. Circulation 1989; 80: 353-360.
26. Miyamoto S, Nagaya N, Satoh T, et al. Clinical correlates and prognostic significance of 6-minute walk test in patients with pulmonary hypertension. Comparison with cardiopulmonary exercise testing. Am J Respir Crit Care Med 2000; 161: 487-492.
27. Sitbon O, Humbert M, Nunes H, et al. Long-term intravenous epoprostenol infusion in primary pulmonary hypertension: prognostic factors and survival. J Am Coll Cardiol 2002; 40: 780-788.
28. McLaughlin V, Shillington A, Rich S. Survival in primary pulmonary hypertension. The impact of epoprostenol therapy. Circulation 2002; 106: 1477-1482.
29. McGregor M, Sniderman A. On pulmonary vascular resistance: the need for more precise definition. Am J Cardiol 1985; 55: 217-221.
30. Castelain V, Chemla D, Humbert M, et al. Pulmonary artery pressure-flow relations after prostacyclin in primary pulmonary hypertension. Am J Respir Crit Care Med 2002; 165: 338-340.
31. Abdel Kafi S, Mélot C, Vachiéry JL, Brimioulle S, Naeije R. Partitioning of pulmonary vascular resistance in primary pulmonary hypertension. J Am Coll Cardiol 1998; 31: 1372-1376.
32. Laskey W, Ferrari V, Palevsky H, Kussmaul W. Pulmonary artery hemodynamics in primary pulmonary hypertension. J Am Coll Cardiol 1993; 21: 406-412.
33. Reeves JT, Groves BM, Turkevitch D, Morrisson DA, Trapp JA. Right ventricular function in pulmonary hypertension. In: Pulmonary Vascular Physiology and Pathophysiology. Weir EK, Reeves JT, eds. Lung Biology in Health and Disease. Vol. 38. New York, NY, Marcel Dekker, 1989; pp. 325-351.
34. Nakayama Y, Nakanishi N, Sugimachi M, et al. Characteristics of pulmonary artery pressure waveform for differential diagnosis of chronic pulmonary thromboembolism and primary pulmonary hypertension. J Am Coll Cardiol 1997; 29: 1311-1316.
35. Nakayama Y, Sugimachi M, Nakanishi, et al. Noninvasive differential diagnosis between chronic pulmonary thromboembolism and primary pulmonary hypertension by means of Doppler ultrasound measurement. J Am Coll Cardiol 1998; 31: 1367-1371.
36. Nakayama Y, Nakanishi N, Hayashi T, et al. Pulmonary artery reflection for differentially diagnosing primary pulmonary hypertension and chronic pulmonary thromboembolism. J Am Coll Cardiol 2001; 38: 214-218.
37. Castelain V, Herve P, Lecarpentier Y, Duroux P, Simonneau G, Chemla V. Pulmonary artery pulse pressure and wave reflection in chronic pulmonary thromboembolism and primary pulmonary hypertension. J Am Coll Cardiol 2001; 37: 1085-1092.
38. Raeside DR, Chalmer G, Clelland J, Madhok R, Peacock AJ. Pulmonary artery pressure variation in patients with connective tissue disease: 24 hour ambulatory pressure monitoring. Thorax 1998: 53: 857-862.
39. Sun X-G, Oudiz RJ, Hansen JE, Wasserman K. Exercise pathophysiology in primary pulmonary vascular hypertension. Circulation 2001; 104: 429-435.
40. Riley MS, Porszasz J, Engelen MP, Brundage BH, Wasserman K. Gas exchange responses to continuous incremental cycle ergometry exercise in primary pulmonary hypertension in humans. Eur J Appl Physiol 2000; 83: 63-70.
41. Wensel R, Opitz CF, Anker SD, et al. Assessment of survival in patients with primary pulmonary hypertension: importance of cardiopulmonary exercise testing. Circulation 2002; 106: 319-324.
42. Wax D, Garofano R, Barst RJ. Effects of long-term infusion of prostacyclin on exercise performance in patients with primary pulmonary hypertension. Chest 1999; 116: 914-920.
43. Raeside DA, Smith A, Brown A, et al. Pulmonary artery pressure measurement during exercise testing in patients with suspected pulmonary hypertension. Eur Respir J 2000; 16: 282-287.
44. Barst RJ, McGoon M, McLaughlin V, et al. Beraprost therapy for pulmonary arterial hypertension. J Am Coll Cardiol 2003; 41: 2119-2125.
45. Barst RJ, Langleben D, Frost A, et al. Sitaxsentan therapy for pulmonary arterial hypertension. Am J Respir Crit Care Med 2004; 169: 441-447.
46. Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473-483.
47. Hunt SM, McEwen J, McKenna SP. Measuring Health Status. London, Croom Helm, 1986.
48. Anon. EuroQol - a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990; 16: 199-208.
49. Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Am Heart J 1992; 124: 1017-1025.
50. McKenna SP, Doward LC, Kohlmann T, et al. International development of the Quality of Life in Depression Scale (QLDS). J Affect Disord 2001; 63: 189-199.
51. Sanders C, Egger M, Tallon D, Frankel S. Reporting on quality of life in randomised controlled trials. BMJ 1998; 317: 1191-1194.
52. World Health Organization. The International Classification of Impairments, Disabilities and Handicaps. Geneva, World Health Organization, 1980.
53. Doward LC, McKenna SP, Meads DM, Ratcliffe J, Whalley D, Langley PC. Investigation into the feasibility of deriving relative and absolute utility from the Recurrent Genital Herpes Quality of Life questionnaire (RGHQoL). Value Health 2002; 5: 573-574.
54. McKenna SP, Whalley D, Doward LC. Which outcomes are important in schizophrenia trials? Int J Methods Psychiatr Res 2000; 9: S58-S67.
55. Patrick DL, Bush JW, Chen MM. Methods for measuring levels of well-being for a health status index. Health Serv Res 1973; 8: 228-245.
56. Hunt SM, McKenna SP. The QLDS: a scale for the measurement of quality of life in depression. Health Policy 1992; 22: 307-319.
57. Berzon R, Hays RD, Shumaker SA., International use, application and performance of health-related quality of life instruments. Qual Life Res 1993; 2: 367-368.
58. Cacoub P, Dorent R, Maistre G, et al. Endothelin-1 in primary pulmonary hypertension and Eisenmenger syndrome. Am J Cardiol 1993; 71: 448-450.
59. Langleben D, Barst RJ, Badesch D, et al. Continuous infusion of epoprostenol improves the net balance between pulmonary endothelin-1 clearance and release in primary pulmonary hypertension. Circulation 1999; 99: 3266-3271.
60. Rubens C, Ewert R, Halank M, et al. Big endothelin-1 and endothelin-1 plasma levels are correlated with the severity of primary pulmonary hypertension. Chest 2001; 120: 1562-1569.
61. Stewart DJ, Levy RD, Cernacek P, Langleben D. Increased plasma endothelin-1 in pulmonary hypertension: marker or mediator of disease? Ann Intern Med 1991; 114: 464-469.
62. Wilkens H, Bauer M, Forestier N, et al. Influence of inhaled iloprost on transpulmonary gradient of big endothelin in patients with pulmonary hypertension. Circulation 2003; 107: 1509-1513.
63. Christman BW, McPherson CD, Newman JH, et al. An imbalance between excretion of thromboxane and prostacyclin metabolites in pulmonary hypertension. N Engl J Med 1992; 327: 70-75.
64. Friedman R, Mears JG, Barst RJ. Continuous injection of prostacyclin normalizes plasma markers of endothelial cell injury and platelet aggregation in primary pulmonary hypertension. Circulation 1997; 96: 2782-2784.
65. Ghofrani HA, Wiedemann R, Rose F, et al. Lung cGMP release subsequent to NO inhalation in pulmonary hypertension: responders versus nonresponders. Eur Respir J 2002; 19: 664-671.
66. Bogdan M, Humbert M, Francoual J, et al. Urinary cGMP concentrations in severe primary pulmonary hypertension. Thorax 1998; 53: 1059-1062.
67. Lopes AA, Maeda NY. Circulating von Willebrand factor antigen as a predictor of short-term prognosis in pulmonary hypertension. Chest 1998; 114: 1276-1282.
68. Veyradier A, Nishikubo T, Humbert M, et al. Improvement of von Willebrand factor proteolysis after prostacyclin infusion in severe pulmonary arterial hypertension. Circulation 2000; 102: 2460-2462.
69. Shitrit D, Bendayan D, Rudensky B, et al. Significance of a plasma d-dimer test in patients with primary pulmonary hypertension. Chest 2002; 122: 1674-1678.
70. Hervé P, Launay JM, Scrobohaci ML, et al. Increased plasma serotonin in primary pulmonary hypertension. Am J Med 1995; 99: 249-254.
71. Kéreveur A, Callebert J, Humbert M, et al. High plasma serotonin levels in primary pulmonary hypertension: effect of long-term epoprostenol (prostacyclin) therapy. Arterioscler Thromb Vasc Biol 2000; 20: 2233-2239.
72. Humbert M, Monti G, Brenot F, et al. Increased interleukin-1 and interleukin-6 serum concentrations in severe primary pulmonary hypertension. Am J Respir Crit Care Med 1995; 151: 1628-1631.
73. Nagaya N, Nishikimi T, Uematsu M, et al. Plasma brain natriuretic peptide as a prognostic indicator in patients with primary pulmonary hypertension. Circulation 2000; 102: 865-870.
74. Wiedemann R, Ghofrani HA, Weissmann N, et al. Atrial natriuretic peptide in severe primary and nonprimary pulmonary hypertension: response to iloprost inhalation. J Am Coll Cardiol 2001; 38: 1130-1136.
75. Torbicki A, Kurzyna M, Kuca P, et al. Detectable serum cardiac troponin T as a marker of poor prognosis among patients with chronic precapillary pulmonary hypertension. Circulation 2003; 108: 844-848.
76. Nagaya N, Uematsu M, Satoh T, et al. Serum uric acid levels correlate with the severity and the mortality of primary pulmonary hypertension. Am J Respir Crit Care Med 1999; 160: 487-492.
77. Cracowski JL, Cracowski C, Bessard G, et al. Increased lipid peroxidation in patients with pulmonary hypertension. Am J Respir Crit Care Med 2001; 164: 1038-1042.