Rationale and design of the soluble guanylate cyclase stimulator in heart failure studies (SOCRATES)

European Journal of Heart Failure

Volumn 16, Issue 9, 2014, Pages 1026-1038

  Pieske, Burkert ^a   Butler, Javed ^b   Filippatos, Gerasimos ^c   Lam, Carolyn ^d   Maggioni, Aldo Pietro ^e   Ponikowski, Piotr ^f   Shah, Sanjiv ^g   Solomon, Scott ^h   Kraigher Krainer, Elisabeth ^a   Samano, Eliana Tibana ⁱ   Scalise, Andrea Viviana ^j   Müller, Katharina ^k   Roessig, Lothar ^k   Gheorghiade, Mihai ^g  

^a MEDICAL UNIVERSITY OF GRAZ   (Austria)

^b EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^d Cardiovascular Research Institute   (Singapore)

^e ANMCO RESEARCH CENTER   (Italy)

^f WROCLAW MEDICAL UNIVERSITY   (Poland)

^g NORTHWESTERN UNIVERSITY   (United States)

^h BRIGHAM AND WOMEN S HOSPITAL   (United States)

ⁱ Global Development   (Brazil)

^j Bayer HealthCare AG   (Spain)

^k BAYER PHARMA AG   (Germany)

more..

Author keywords

Left atrial volume; Natriuretic peptides; Preserved ejection fraction; Reduced ejection fraction; Soluble guanylate cyclase; Worsening chronic heart failure

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; BRAIN NATRIURETIC PEPTIDE; CREATININE; PLACEBO; VERICIGUAT; CELL RECEPTOR; GUANYLATE CYCLASE; PEPTIDE FRAGMENT; PRO-BRAIN NATRIURETIC PEPTIDE (1-76); PROTEIN PRECURSOR; SOLUBLE GUANYLYL CYCLASE;

ACUTE KIDNEY FAILURE; ARTICLE; CREATININE BLOOD LEVEL; DRUG SAFETY; ECHOCARDIOGRAPHY; GLOMERULUS FILTRATION RATE; HEART FAILURE; HEART FAILURE WITH PRESERVED EJECTION FRACTION; HEART RHYTHM; HUMAN; MULTICENTER STUDY (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); SINUS RHYTHM; TREATMENT DURATION; AGED; BLOOD; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HEART STROKE VOLUME; MALE; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PATHOPHYSIOLOGY; PHASE 2 CLINICAL TRIAL; PHYSIOLOGY; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; AGED; DOUBLE-BLIND METHOD; FEMALE; GUANYLATE CYCLASE; HEART FAILURE; HUMANS; MALE; NATRIURETIC PEPTIDE, BRAIN; PEPTIDE FRAGMENTS; PROGNOSIS; PROTEIN PRECURSORS; RECEPTORS, CYTOPLASMIC AND NUCLEAR; STROKE VOLUME; TREATMENT OUTCOME;

EID: 84908228649     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1002/ejhf.135     Document Type: Article

References (49)

1. Gheorghiade M, Orlandi C, Burnett JC, Demets D, Grinfeld L, Maggioni A, Swedberg K, Udelson JE, Zannad F, Zimmer C, Konstam MA. Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the Efficacy of Vasopressin antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST). J Card Fail 2005;11:260-269.
2. Konstam MA, Gheorghiade M, Burnett JC Jr., Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: The EVEREST Outcome Trial. JAMA 2007;297:1319-1331.
3. Gheorghiade M, Albaghdadi M, Zannad F, Fonarow GC, Bohm M, Gimpelewicz C, Botha J, Moores S, Lewis EF, Rattunde H, Maggioni A. Rationale and design of the multicentre, randomized, double-blind, placebo-controlled Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT). Eur J Heart Fail 2011;13:100-106.
4. Gheorghiade M, Bohm M, Greene SJ, Fonarow GC, Lewis EF, Zannad F, Solomon SD, Baschiera F, Botha J, Hua TA, Gimpelewicz CR, Jaumont X, Lesogor A, Maggioni AP. Effect of aliskiren on postdischarge mortality and heart failure readmissions among patients hospitalized for heart failure: The ASTRONAUT randomized trial. JAMA 2013;309:1125-1135.
5. McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Reiner Z, SechtemU, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2012;14:803-869.
6. Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2013;128:e240-e319.
7. Brutsaert DL. Cardiac endothelial-myocardial signaling: Its role in cardiac growth, contractile performance, and rhythmicity. Physiol Rev 2003;83:59-115.
8. Gheorghiade M, Marti CN, Sabbah HN, Roessig L, Greene SJ, Bohm M, Burnett JC, Campia U, Cleland JG, Collins SP, Fonarow GC, Levy PD, Metra M, Pitt B, Ponikowski P, Sato N, Voors AA, Stasch JP, Butler J. Soluble guanylate cyclase: A potential therapeutic target for heart failure. Heart Fail Rev 2013;18:123-134.
9. Buys ES, Sips P, Vermeersch P, Raher MJ, Rogge E, Ichinose F, Dewerchin M, Bloch KD, Janssens S, Brouckaert P. Gender-specific hypertension and responsiveness to nitric oxide in sGCalpha1 knockout mice. Cardiovasc Res 2008;79:179-186.
10. Cawley SM, Kolodziej S, Ichinose F, Brouckaert P, Buys ES, Bloch KD. sGCa1 mediates the negative inotropic effects of NO in cardiac myocytes independent of changes in calcium handling. Am J Physiol Heart Circ Physiol 2011;301:H157-H163.
11. van Heerebeek L, Hamdani N, Falcao-Pires I, Leite-Moreira AF, Begieneman MP, Bronzwaer JG, van der Velden J, Stienen GJ, Laarman GJ, Somsen A, Verheugt FW, Niessen HW, Paulus WJ. Low myocardial protein kinase G activity in heart failure with preserved ejection fraction. Circulation 2012;126:830-839.
12. Tsai EJ, Kass DA. Cyclic GMP signaling in cardiovascular pathophysiology and therapeutics. Pharmacol Ther 2009;122:216-238.
13. Lam CS, Brutsaert DL. Endothelial dysfunction: A pathophysiologic factor in heart failure with preserved ejection fraction. J Am Coll Cardiol 2012;60:1787-1789.
14. Paulus WJ, Tschope C. A novel paradigm for heart failure with preserved ejection fraction: comorbidities drive myocardial dysfunction and remodeling through coronary micro vascular endothelial inflammation. J Am Coll Cardiol 2013;62:263-271.
15. Greene SJ, Gheorghiade M, Borlaug BA, Pieske B, Vaduganathan M, Burnett JC Jr, Roessig L, Stasch JP, Solomon SD, Paulus WJ, Butler J. The cGMP signaling pathway as a therapeutic target in heart failure with preserved ejection fraction. J Am Heart Assoc 2013;2:e000536.
16. Stasch JP, Pacher P, Evgenov OV. Soluble guanylate cyclase as an emerging therapeutic target in cardiopulmonary disease. Circulation 2011;123:2263-2273.
17. Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P. Acute renal failure-definition, outcome measures, animal models, fluid therapy and information technology needs: The Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care 2004;8:R204-R212.
18. Ambrosy AP, Pang PS, Khan S, Konstam MA, Fonarow GC, Traver B, Maggioni AP, Cook T, Swedberg K, Burnett JC Jr, Grinfeld L, Udelson JE, Zannad F, Gheorghiade M. Clinical course and predictive value of congestion during hospitalization in patients admitted for worsening signs and symptoms of heart failure with reduced ejection fraction: Findings from the EVEREST trial. Eur Heart J 2013;34:835-843.
19. Munzel T, Daiber A, Mulsch A. Explaining the phenomenon of nitrate tolerance. Circ Res 2005;97:618-628.
20. Oelze M, Knorr M, Kroller-Schon S, Kossmann S, Gottschlich A, Rummler R, Schuff A, Daub S, Doppler C, Kleinert H, Gori T, Daiber A, Munzel T. Chronic therapy with isosorbide-5-mononitrate causes endothelial dysfunction, oxidative stress, and a marked increase in vascular endothelin-1 expression. Eur Heart J 2013;34:3206-3216.
21. Cole RT, Kalogeropoulos AP, Georgiopoulou VV, Gheorghiade M, Quyyumi A, Yancy C, Butler J. Hydralazine and isosorbide dinitrate in heart failure: historical perspective, mechanisms, and future directions. Circulation 2011;123:2414-2422.
22. Redfield MM, Chen HH, Borlaug BA, Semigran MJ, Lee KL, Lewis G, LeWinter MM, Rouleau JL, Bull DA, Mann DL, Deswal A, Stevenson LW, Givertz MM, Ofili EO, O'Connor CM, Felker GM, Goldsmith SR, Bart BA, McNulty SE, Ibarra JC, Lin G, Oh JK, Patel MR, Kim RJ, Tracy RP, Velazquez EJ, Anstrom KJ, Hernandez AF, Mascette AM, Braunwald E. Effect of phosphodiesterase-5 inhibition on exercise capacity and clinical status in heart failure with preserved ejection fraction: A randomized clinical trial. JAMA 2013;309:1268-1277.
23. Boerrigter G, Costello-Boerrigter LC, Cataliotti A, Tsuruda T, Harty GJ, Lapp H, Stasch JP, Burnett JC Jr. Cardiorenal and humoral properties of a novel direct soluble guanylate cyclase stimulator BAY 41-2272 in experimental congestive heart failure. Circulation 2003;107:686-689.
24. Gheorghiade M, Greene SJ, Filippatos G, Erdmann E, Ferrari R, Levy PD, Maggioni A, Nowack C, Mebazaa A. Cinaciguat, a soluble guanylate cyclase activator: results from the randomized, controlled, phase IIb COMPOSE programme in acute heart failure syndromes. Eur J Heart Fail 2012;14:1056-1066.
25. Voors AA, van Veldhuisen DJ. Why do drugs for acute heart failure fail? Eur J Heart Fail 2012;14:955-956.
26. Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med 2013;369:330-340.
27. Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med 2013;369:319-329.
28. Bonderman D, Ghio S, Felix SB, Ghofrani HA, Michelakis E, Mitrovic V, Oudiz RJ, Boateng F, Scalise AV, Roessig L, Semigran MJ. Riociguat for patients with pulmonary hypertension caused by systolic left ventricular dysfunction: A phase IIb double-blind, randomized, placebo-controlled, dose-ranging hemodynamic study. Circulation 2013;128:502-511.
29. Kalogeropoulos AP, Georgiopoulou VV, Borlaug BA, Gheorghiade M, Butler J. Left ventricular dysfunction with pulmonary hypertension: part 2: prognosis, noninvasive evaluation, treatment, and future research. Circ Heart Fail 2013;6:584-593.
30. Swedberg K, Pfeffer M, Granger C, Held P, McMurray J, Ohlin G, Olofsson B, Ostergren J, Yusuf S. Candesartan in heart failure-assessment of reduction in mortality and morbidity (CHARM): rationale and design. Charm-Programme Investigators. J Card Fail 1999;5:276-282.
31. Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med 2008;359:2456-2467.
32. Shah SJ, Heitner JF, Sweitzer NK, Anand IS, Kim HY, Harty B, Boineau R, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Lewis EF, Markov V, O'Meara E, Kobulia B, Shaburishvili T, Solomon SD, Pitt B, Pfeffer MA, Li R. Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. Circ Heart Fail 2013;6:184-192.
33. Maisel AS, McCord J, Nowak RM, Hollander JE, Wu AH, Duc P, Omland T, Storrow AB, Krishnaswamy P, Abraham WT, Clopton P, Steg G, Aumont MC, Westheim A, Knudsen CW, Perez A, Kamin R, Kazanegra R, Herrmann HC, McCullough PA. Bedside B-type natriuretic peptide in the emergency diagnosis of heart failure with reduced or preserved ejection fraction. Results from the Breathing Not Properly Multinational Study. J Am Coll Cardiol 2003;41:2010-2017.
34. Bishu K, Deswal A, Chen HH, Le Winter MM, Lewis GD, Semigran MJ, Borlaug BA, McNulty S, Hernandez AF, Braunwald E, Redfield MM. Biomarkers in acutely decompensated heart failure with preserved or reduced ejection fraction. Am Heart J 2012;164:763-770 e763.
35. van Veldhuisen DJ, Linssen GC, Jaarsma T, van Gilst WH, Hoes AW, Tijssen JG, Paulus WJ, Voors AA, Hillege HL. B-type natriuretic peptide and prognosis in heart failure patients with preserved and reduced ejection fraction. J Am Coll Cardiol 2013;61:1498-1506.
36. Cleland JG, Taylor J, Freemantle N, Goode KM, Rigby AS, Tendera M. Relationship between plasma concentrations of N-terminal pro brain natriuretic peptide and the characteristics and outcome of patients with a clinical diagnosis of diastolic heart failure: A report from the PEP-CHF study. Eur J Heart Fail 2012;14: 487-494.
37. Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: A consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J 2007;28:2539-2550.
38. Lee DS, Schull MJ, Alter DA, Austin PC, Laupacis A, Chong A, Tu JV, Stukel TA. Early deaths in patients with heart failure discharged from the emergency department: A population-based analysis. Circ Heart Fail 2010;3:228-235.
39. Maisel A, Hollander JE, Guss D, McCullough P, Nowak R, Green G, Saltzberg M, Ellison SR, Bhalla MA, Bhalla V, Clopton P, Jesse R. Primary results of the Rapid Emergency Department Heart Failure Outpatient Trial (REDHOT). A multicenter study of B-type natriuretic peptide levels, emergency department decision making, and outcomes in patients presenting with shortness of breath. J Am Coll Cardiol 2004;44:1328-1333.
40. Skali H, Dwyer EM, Goldstein R, Haigney M, Krone R, Kukin M, Lichstein E, McNitt S, Moss AJ, Pfeffer MA, Solomon SD. Prognosis and response to therapy of first inpatient and outpatient heart failure event in a heart failure clinical trial: MADIT-CRT. Eur J Heart Fail 2014;16:560-565.
41. Maisel A. Biomonitoring and biomarker-guided therapy: The next step in heart failure and biomarker research. J Am Coll Cardiol 2011;58:1890-1892.
42. Januzzi JL, Troughton R. Are serial BNP measurements useful in heart failure management? Serial natriuretic peptide measurements are useful in heart failure management. Circulation. 2013;127:500-507; discussion 508.
43. Grewal J, McKelvie RS, Persson H, Tait P, Carlsson J, Swedberg K, Ostergren J, Lonn E. Usefulness of N-terminal pro-brain natriuretic peptide and brain natriuretic peptide to predict cardiovascular outcomes in patients with heart failure and preserved left ventricular ejection fraction. Am J Cardiol 2008;102:733-737.
44. Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation 2011;124:2491-2501.
45. Ohtani T, Mohammed SF, Yamamoto K, Dunlay SM, Weston SA, Sakata Y, Rodeheffer RJ, Roger VL, Redfield MM. Diastolic stiffness as assessed by diastolic wall strain is associated with adverse remodelling and poor outcomes in heart failure with preserved ejection fraction. Eur Heart J 2012;33:1742-1749.
46. Kuperstein R, Goldenberg I, Moss AJ, Solomon S, Bourgoun M, Shah A, McNitt S, Zareba W, Klempfner R. Left atrial volume and the benefit of cardiac resynchronization therapy in the MADIT-CRT Trial. Circ Heart Fail 2013;7: 154-160.
47. Zannad F, McMurray JJ, Krum H, vanVeldhuisen DJ, Swedberg K, Shi H, Vincent J, Pocock SJ, Pitt B. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med 2011;364:11-21.
48. Solomon SD, Zile M, Pieske B, Voors A, Shah A, Kraigher-Krainer E, Shi V, Bransford T, Takeuchi M, Gong J, Lefkowitz M, Packer M, McMurray JJ. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: A phase 2 double-blind randomised controlled trial. Lancet 2012;380:1387-1395.
49. Edelmann F, Wachter R, Schmidt AG, Kraigher-Krainer E, Colantonio C, Kamke W, Duvinage A, Stahrenberg R, Durstewitz K, Loffler M, Dungen HD, Tschope C, Herrmann-Lingen C, Halle M, Hasenfuss G, Gelbrich G, Pieske B. Effect of spironolactone on diastolic function and exercise capacity in patients with heart failure with preserved ejection fraction: The Aldo-DHF randomized controlled trial. JAMA 2013;309:781-791.