Effect of valsartan on systemic right ventricular function: A double-blind, randomized, placebo-controlled pilot trial

Circulation

Volumn 127, Issue 3, 2013, Pages 322-330

  Van Der Bom, Teun ^a,b   Winter, Michiel M ^a,b   Bouma, Berto J ^a   Groenink, Maarten ^a   Vliegen, Hubert W ^c   Pieper, Petronella G ^d   Van Dijk, Arie P J ^e   Sieswerda, Gertjan T ^f   Roos Hesselink, Jolien W ^g   Zwinderman, Aeilko H ^a   Mulder, Barbara J M ^a,b  

^a ACADEMIC MEDICAL CENTER   (Netherlands)

^b ROYAL NETHERLANDS ACADEMY OF ARTS AND SCIENCES   (Netherlands)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^e RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^f UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^g ERASMUS MEDICAL CENTER   (Netherlands)

Author keywords

angiotensin II receptor blockers; heart defects, congenital; magnetic resonance imaging; renin angiotensin system; transposition of great vessels

Indexed keywords

ANGIOTENSIN RECEPTOR ANTAGONIST; ANTIARRHYTHMIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; DIURETIC AGENT; PLACEBO; VALSARTAN;

ADULT; ANGIONEUROTIC EDEMA; ARTICLE; CARDIOVASCULAR MAGNETIC RESONANCE; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY COUGH; EXERCISE; FATIGUE; FEMALE; FOLLOW UP; GREAT VESSELS TRANSPOSITION; HEART ARRHYTHMIA; HEART PALPITATION; HEART RIGHT VENTRICLE EJECTION FRACTION; HEART RIGHT VENTRICLE ENDDIASTOLIC VOLUME; HEART RIGHT VENTRICLE FUNCTION; HEART RIGHT VENTRICLE HYPERTROPHY; HEART RIGHT VENTRICLE VOLUME; HEART SURGERY; HUMAN; HYPERTENSION; HYPOTENSION; LIVER ENZYEM BLOOD LEVEL; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; MULTIDETECTOR COMPUTED TOMOGRAPHY; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PILOT STUDY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN BRUISING;

ADULT; ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; DOUBLE-BLIND METHOD; EXERCISE TOLERANCE; FEMALE; FOLLOW-UP STUDIES; HEART DEFECTS, CONGENITAL; HEART VENTRICLES; HUMANS; MAGNETIC RESONANCE IMAGING; MALE; MULTIDETECTOR COMPUTED TOMOGRAPHY; OUTCOME ASSESSMENT (HEALTH CARE); PILOT PROJECTS; QUALITY OF LIFE; STROKE VOLUME; TETRAZOLES; TRANSPOSITION OF GREAT VESSELS; VALINE; VENTRICULAR DYSFUNCTION, RIGHT;

EID: 84872675363     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.112.135392     Document Type: Article

References (45)

1. Wilson NJ, Clarkson PM, Barratt-Boyes BG, Calder AL, Whitlock RM, Easthope RN, Neutze JM. Long-term outcome after the Mustard repair for simple transposition of the great arteries: 28-year follow-up. J Am Coll Cardiol. 1998;32:758-765.
2. Warnes CA, Somerville J. Transposition of the great arteries: late results in adolescents and adults after the Mustard procedure. Br Heart J. 1987;58:148-155.
3. Winter MM, Bouma BJ, van Dijk AP, Groenink M, Nieuwkerk PT, van der Plas MN, Sieswerda GT, Konings TC, Mulder BJ. Relation of physical activity, cardiac function, exercise capacity, and quality of life in patients with a systemic right ventricle. Am J Cardiol. 2008;102:1258-1262.
4. Winter MM, Reisma C, Kedde H, Bouma BJ, Vis JC, Luijendijk P, de Witte P, Zwinderman AH, Vliegen HW, Pieper PG, van Dijk AP, Mulder BJ. Sexuality in adult patients with congenital heart disease and their partners. Am J Cardiol. 2010;106:1163-1168, 1168.e1.
5. Roos-Hesselink JW, Meijboom FJ, Spitaels SE, van Domburg R, van Rijen EH, Utens EM, McGhie J, Bos E, Bogers AJ, Simoons ML. Decline in ventricular function and clinical condition after Mustard repair for transposition of the great arteries (a prospective study of 22-29 years). Eur Heart J. 2004;25:1264-1270.
6. Piran S, Veldtman G, Siu S, Webb GD, Liu PP. Heart failure and ventricular dysfunction in patients with single or systemic right ventricles. Circulation. 2002;105:1189-1194.
7. Dodge-Khatami A, Tulevski II, Bennink GB, Hitchcock JF, de Mol BA, van der Wall EE, Mulder BJ. Comparable systemic ventricular function in healthy adults and patients with unoperated congenitally corrected transposition using MRI dobutamine stress testing. Ann Thorac Surg. 2002;73:1759-1764.
8. van der Zedde J, Oosterhof T, Tulevski II, Vliegen HW, Mulder BJ. Comparison of segmental and global systemic ventricular function at rest and during dobutamine stress between patients with transposition and congen-itally corrected transposition. Cardiol Young. 2005;15:148-153.
9. Tulevski II, Zijta FM, Smeijers AS, Dodge-Khatami A, van der Wall EE, Mulder BJ. Regional and global right ventricular dysfunction in asymptomatic or minimally symptomatic patients with congenitally corrected transposition. Cardiol Young. 2004;14:168-173.
10. Fredriksen PM, Chen A, Veldtman G, Hechter S, Therrien J, Webb G. Exercise capacity in adult patients with congenitally corrected transposition of the great arteries. Heart. 2001;85:191-195.
11. Winter MM, van der Bom T, de Vries LC, Balducci A, Bouma BJ, Pieper PG, van Dijk AP, van der Plas MN, Picchio FM, Mulder BJ. Exercise training improves exercise capacity in adult patients with a systemic right ventricle: a randomized clinical trial. Eur Heart J. 2012;33:1378-1385.
12. Gelatt M, Hamilton RM, McCrindle BW, Connelly M, Davis A, Harris L, Gow RM, Williams WG, Trusler GA, Freedom RM. Arrhythmia and mortality after the Mustard procedure: a 30-year single-center experience. J Am Coll Cardiol. 1997;29:194-201.
13. Schwerzmann M, Salehian O, Harris L, Siu SC, Williams WG, Webb GD, Colman JM, Redington A, Silversides CK. Ventricular arrhythmias and sudden death in adults after a Mustard operation for transposition of the great arteries. Eur Heart J. 2009;30:1873-1879.
14. Winter MM, Bouma BJ, Hardziyenka M, De Bruin-Bon RH, Tan HL, Konings TC, Van Dijk AP, Mulder BJ. Echocardiographic determinants of the clinical condition in patients with a systemic right ventricle. Echocar-diography. 2010;27:1247-1255.
15. Granger CB, McMurray JJ, Yusuf S, Held P, Michelson EL, Olofsson B, Ostergren J, Pfeffer MA, Swedberg K; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function intolerant to angiotensin-converting-enzyme inhibitors: the CHARM-Alternative trial. Lancet. 2003;362:772-776.
16. Jong P, Yusuf S, Rousseau MF, Ahn SA, Bangdiwala SI. Effect of enalapril on 12-year survival and life expectancy in patients with left ventricular systolic dysfunction: a follow-up study. Lancet. 2003;361:1843-1848.
17. Sharpe DN, Murphy J, Coxon R, Hannan SF. Enalapril in patients with chronic heart failure: a placebo-controlled, randomized, double-blind study. Circulation. 1984;70:271-278.
18. Konstam MA, Rousseau MF, Kronenberg MW, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D; SOLVD Investigators. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dysfunction in patients with heart failure. Circulation. 1992;86:431-438.
19. Krum H, Carson P, Farsang C, Maggioni AP, Glazer RD, Aknay N, Chiang YT, Cohn JN. Effect of valsartan added to background ACE inhibitor therapy in patients with heart failure: results from Val-HeFT. Eur J Heart Fail. 2004;6:937-945.
20. Riegger GA, Bouzo H, Petr P, Münz J, Spacek R, Pethig H, von Beh-ren V, George M, Arens H; Symptom, Tolerability, Response to Exercise Trial of Candesartan Cilexetil in Heart Failure (STRETCH) Investigators. Improvement in exercise tolerance and symptoms of congestive heart failure during treatment with candesartan cilexetil. Circulation. 1999;100:2224-2230.
21. Kramer BL, Massie BM, Topic N. Controlled trial of captopril in chronic heart failure: a rest and exercise hemodynamic study. Circulation. 1983;67:807-816.
22. Cleland JG, Shah D, Krikler S, Dritsas A, Nihoyannopoulos P, Frost G, Oakley CM. Effects of lisinopril on cardiorespiratory, neuroendocrine, and renal function in patients with asymptomatic left ventricular dysfunction. Br Heart J. 1993;69:512-515.
23. Dickstein K, Barvik S, Aarsland T. Effects of long-term enalapril therapy on cardiopulmonary exercise performance after myocardial infarction. Circulation. 1991;83:1895-1904.
24. Konstam MA, Kronenberg MW, Rousseau MF, Udelson JE, Melin J, Stewart D, Dolan N, Edens TR, Ahn S, Kinan D; SOLVD (Studies of Left Ventricular Dysfunction) Investigators. Effects of the angiotensin converting enzyme inhibitor enalapril on the long-term progression of left ventricular dilatation in patients with asymptomatic systolic dysfunction. Circulation. 1993;88(pt 1):2277-2283.
25. Urata H, Healy B, Stewart RW, Bumpus FM, Husain A. Angiotensin II receptors in normal and failing human hearts. J Clin Endocrinol Metab. 1989;69:54-66.
26. Winter MM, Bouma BJ, Groenink M, Konings TC, Tijssen JG, van Veld-huisen DJ, Mulder BJ. Latest insights in therapeutic options for systemic right ventricular failure: a comparison with left ventricular failure. Heart. 2009;95:960-963.
27. Szymański P, Klisiewicz A, Lubiszewska B, Lipczyńska M, Kowalski M, Janas J, Hoffman P. Gender differences in angiotensin II and aldosterone secretion in patients with pressure overloaded systemic right ventricles are similar to those observed in systemic arterial hypertension. Int J Cardiol. 2011;147:366-370.
28. Therrien J, Provost Y, Harrison J, Connelly M, Kaemmerer H, Webb GD. Effect of angiotensin receptor blockade on systemic right ventricular function and size: a small, randomized, placebo-controlled study. Int J Cardiol. 2008;129:187-192.
29. Dore A, Houde C, Chan KL, Ducharme A, Khairy P, Juneau M, Marcotte F, Mercier LA. Angiotensin receptor blockade and exercise capacity in adults with systemic right ventricles: a multicenter, randomized, placebo-controlled clinical trial. Circulation. 2005;112:2411-2416.
30. Hechter SJ, Fredriksen PM, Liu P, Veldtman G, Merchant N, Freeman M, Therrien J, Benson L, Siu S, Webb G. Angiotensin-converting enzyme inhibitors in adults after the Mustard procedure. Am J Cardiol. 2001;87:660-663, A11.
31. Lester SJ, McElhinney DB, Viloria E, Reddy GP, Ryan E, Tworetzky W, Schiller NB, Foster E. Effects of losartan in patients with a systemically functioning morphologic right ventricle after atrial repair of transposition of the great arteries. Am J Cardiol. 2001;88:1314-1316.
32. Robinson B, Heise CT, Moore JW, Anella J, Sokoloski M, Eshagh-pour E. Afterload reduction therapy in patients following intraatrial baffe operation for transposition of the great arteries. Pediatr Cardiol. 2002;23:618-623.
33. van der Bom T, Winter MM, Bouma BJ, Groenink M, Vliegen HW, Pieper PG, van Dijk AP, Sieswerda GT, Roos-Hesslink JW, Zwinderman AH, Mulder BJ. Rationale and design of a trial on the effect of angiotensin II receptor blockers on the function of the systemic right ventricle. Am Heart J. 2010;160:812-818.
34. van der Velde ET, Vander VE, Vriend JW, Mannens MM, Uiterwaal CS, Brand R, Mulder BJ. CONCOR, an initiative towards a national registry and DNA-bank of patients with congenital heart disease in the Netherlands: rationale, design, and frst results. Eur J Epidemiol. 2005;20:549-557.
35. Latif F, Tandon S, Obeleniene R, Hankins SR, Berlowitz MS, Enne-zat P V, Le Jemtel TH. Angiotensin II type 1 receptor blockade with 80 and 160 mg valsartan in healthy, normotensive subjects. J Card Fail. 2001;7:265-268.
36. Baruch L, Anand I, Cohen IS, Ziesche S, Judd D, Cohn JN; Vasodilator Heart Failure Trial (V-HeFT) Study Group. Augmented short-and longterm hemodynamic and hormonal effects of an angiotensin receptor blocker added to angiotensin converting enzyme inhibitor therapy in patients with heart failure. Circulation. 1999;99:2658-2664.
37. Zoghbi WA, Enriquez-Sarano M, Foster E, Grayburn PA, Kraft CD, Levine RA, Nihoyannopoulos P, Otto CM, Quinones MA, Rakowski H, Stewart WJ, Waggoner A, Weissman NJ; American Society of Echocar-diography. Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and Doppler echocardiography. J Am Soc Echocardiogr. 2003;16:777-802.
38. Ross RM. ATS/ACCP statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003;167:1451. Letter.
39. Aaronson NK, Muller M, Cohen PD, Essink-Bot ML, Fekkes M, Sand-erman R, Sprangers MA, te Velde A, Verrips E. Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol. 1998;51:1055-1068.
40. Rector T, Kubo S, Cohn J. Patients' self-assessment of their congestive heart failure, part 2: content, reliability and validity of a new measure, the Minnesota Living with Heart Failure Questionnaire. Heart Failure. 1987; 3:198-209.
41. Wendel-Vos GC, Schuit AJ, Saris WH, Kromhout D. Reproducibility and relative validity of the short questionnaire to assess health-enhancing physical activity. J Clin Epidemiol. 2003;56:1163-1169.
42. Hurwitz RA, Caldwell RL, Girod DA, Brown J. Right ventricular systolic function in adolescents and young adults after Mustard operation for transposition of the great arteries. Am J Cardiol. 1996;77:294-297.
43. Tutarel O, Meyer GP, Bertram H, Wessel A, Schieffer B, Westhoff-Bleck M. Safety and effciency of chronic ACE inhibition in symptomatic heart failure patients with a systemic right ventricle. Int J Cardiol. 2012;154:14-16.
44. Francis GS, Benedict C, Johnstone DE, Kirlin PC, Nicklas J, Liang CS, Kubo SH, Rudin-Toretsky E, Yusuf S. Comparison of neuroendocrine activation in patients with left ventricular dysfunction with and without congestive heart failure: a substudy of the Studies of Left Ventricular Dysfunction (SOLVD). Circulation. 1990;82:1724-1729.
45. Bolger AP, Sharma R, Li W, Leenarts M, Kalra PR, Kemp M, Coats AJ, Anker SD, Gatzoulis MA. Neurohormonal activation and the chronic heart failure syndrome in adults with congenital heart disease. Circulation. 2002;106:92-99.