Intracoronary gene transfer of adenylyl cyclase 6 in patients with heart failure: A randomized clinical trial

JAMA Cardiology

Volumn 1, Issue 2, 2016, Pages 163-171

  Hammond, H Kirk ^a,b   Penny, William F ^a,b   Traverse, Jay H ^c   Henry, Timothy D ^c,d   Watkins, Matthew W ^e   Yancy, Clyde W ^f   Sweis, Ranya N ^f   Adler, Eric D ^b   Patel, Amit N ^g   Murray, David R ^h   Ross, Robert S ^a,b   Bhargava, Valmik ^a,b   Maisel, Alan ^a,b   Barnard, Denise D ^a,b   Lai, N Chin ^a,b   Dalton, Nancy D ^a   Lee, Martin L ⁱ   Narayan, Sanjiv M ^a,b,j   Blanchard, Daniel G ^a   Gao, Mei Hua ^a,b  

^a VA SAN DIEGO HEALTHCARE SYSTEM   (United States)

^b UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^c MINNEAPOLIS HEART INSTITUTE FOUNDATION   (United States)

^d CEDARS SINAI MEDICAL CENTER   (United States)

^e UNIVERSITY OF VERMONT COLLEGE OF MEDICINE   (United States)

^f NORTHWESTERN UNIVERSITY   (United States)

^g UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADENYLATE CYCLASE; ADENYLYL CYCLASE 6; PLACEBO; TROPONIN I; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CARDIOPULMONARY EXERCISE TEST; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; HEART ARRHYTHMIA; HEART CATHETERIZATION; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART LEFT VENTRICLE PRESSURE; HOSPITAL ADMISSION; HUMAN; INTENTION TO TREAT ANALYSIS; INTRACORONARY DRUG ADMINISTRATION; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VIRAL GENE DELIVERY SYSTEM; ADENOVIRIDAE; CLINICAL TRIAL; COMPARATIVE STUDY; DIAGNOSTIC IMAGING; DRUG EFFECTS; ECHOCARDIOGRAPHY; EPIDEMIOLOGY; EXERCISE TEST; GENE THERAPY; GENE TRANSFER; GENETICS; HEART LEFT VENTRICLE FUNCTION; HEART STROKE VOLUME; MIDDLE AGED; PATHOPHYSIOLOGY; PROCEDURES; STATISTICS AND NUMERICAL DATA; TREATMENT OUTCOME; TRENDS; UNITED STATES;

ADENOVIRIDAE; ADENYLYL CYCLASES; AGED; CARDIAC CATHETERIZATION; ECHOCARDIOGRAPHY; EXERCISE TEST; FEMALE; GENE TRANSFER TECHNIQUES; GENETIC THERAPY; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; PATIENT ADMISSION; STROKE VOLUME; TREATMENT OUTCOME; UNITED STATES; VENTRICULAR FUNCTION, LEFT;

EID: 85016089086     PISSN: 23806583     EISSN: 23806591     Source Type: Journal    
DOI: 10.1001/jamacardio.2016.0008     Document Type: Article

References (30)

1. Go AS, Mozaffarian D, Roger VL, et al.; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2013 update: a report from the American Heart Association. Circulation. 2013; 127(1):e6-e245.
2. Hall MJ, Levant S, De Frances CJ. Hospitalization for Congestive Heart Failure: United States, 2000-2010. Hyattsville, MD: Centers for Disease Control and Prevention, National Center for Health Statistics; October 2012. National Center for Health Statistics, Data Brief, No. 108.
3. Sunahara RK, Dessauer CW, Gilman AG. Complexity and diversity of mammalian adenylyl cyclases. Annu Rev Pharmacol Toxicol. 1996; 36:461-480.
4. Gao M, Ping P, Post S, Insel PA, Tang R, Hammond HK. Increased expression of adenylylcyclase type VI proportionately increases β-adrenergic receptor-stimulated production of cAMP in neonatal rat cardiac myocytes. Proc Natl Acad Sci USA. 1998; 95(3):1038-1043.
5. Gao MH, Lai NC, Roth DM, et al. Adenylylcyclase increases responsiveness to catecholamine stimulation in transgenic mice. Circulation. 1999; 99(12):1618-1622.
6. Roth DM, Gao MH, Lai NC, et al. Cardiac-directed adenylyl cyclase expression improves heart function in murine cardiomyopathy. Circulation. 1999; 99(24):3099-3102.
7. Roth DM, Bayat H, Drumm JD, et al. Adenylyl cyclase increases survival in cardiomyopathy. Circulation. 2002; 105(16):1989-1994.
8. Lai NC, Roth DM, Gao MH, et al. Intracoronary delivery of adenovirus encoding adenylyl cyclase VI increases left ventricular function and cAMP-generating capacity. Circulation. 2000; 102(19):2396-2401.
9. Lai NC, Roth DM, Gao MH, et al. Intracoronary adenovirus encoding adenylyl cyclase VI increases left ventricular function in heart failure. Circulation. 2004; 110(3):330-336.
10. Bristow MR, Ginsburg R, Minobe W, et al. Decreased catecholamine sensitivity and β-adrenergic-receptor density in failing human hearts. N Engl J Med. 1982; 307(4):205-211.
11. Ping P, Anzai T, Gao M, Hammond HK. Adenylyl cyclase and G protein receptor kinase expression during development of heart failure. Am J Physiol. 1997; 273(2, pt 2):H707-H717.
12. Ishikawa Y, Sorota S, Kiuchi K, et al. Downregulation of adenylylcyclase types V and VI mRNA levels in pacing-induced heart failure in dogs. J Clin Invest. 1994; 93(5):2224-2229.
13. Tang T, Gao MH, Roth DM, Guo T, Hammond HK. Adenylyl cyclase type VI corrects cardiac sarcoplasmic reticulum calcium uptake defects in cardiomyopathy. Am J Physiol Heart Circ Physiol. 2004; 287(5):H1906-H1912.
14. Gao MH, Tang T, Guo T, Sun SQ, Feramisco JR, Hammond HK. Adenylyl cyclase type VI gene transfer reduces phospholamban expression in cardiac myocytes via activating transcription factor 3. J Biol Chem. 2004; 279(37):38797-38802.
15. Gao MH, Miyanohara A, Feramisco JR, Tang T. Activation of pH-domain leucine-rich protein phosphatase 2 (PHLPP2) by agonist stimulation in cardiac myocytes expressing adenylyl cyclase type 6. Biochem Biophys Res Commun. 2009; 384(2): 193-198.
16. Di Bianco R, Shabetai R, Kostuk W, Moran J, Schlant RC, Wright R. A comparison of oral milrinone, digoxin, and their combination in the treatment of patients with chronic heart failure. N Engl J Med. 1989; 320(11):677-683.
17. Timofeyev V, He Y, Tuteja D, et al. Cardiac-directed expression of adenylyl cyclase reverses electrical remodeling in cardiomyopathy. J Mol Cell Cardiol. 2006; 41(1):170-181.
18. Roth DM, Lai NC, Gao MH, et al. Nitroprusside increases gene transfer associated with intracoronary delivery of adenovirus. Hum Gene Ther. 2004; 15(10):989-994.
19. Grines CL, Watkins MW, Helmer G, et al. Angiogenic Gene Therapy (AGENT) trial in patients with stable angina pectoris. Circulation. 2002; 105(11):1291-1297.
20. Henry TD, Grines CL, Watkins MW, et al. Effects of Ad5FGF-4 in patients with angina: an analysis of pooled data from the AGENT-3 and AGENT-4 trials. J Am Coll Cardiol. 2007; 50(11):1038-1046.
21. Jessup M, Abraham WT, Casey DE, et al. 2009 Focused update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009; 119(14):1977-2016.
22. Page E, Cohen-Solal A, Jondeau G, et al. Comparison of treadmill and bicycle exercise in patients with chronic heart failure. Chest. 1994; 106(4):1002-1006.
23. Green CP, Porter CB, Bresnahan DR, Spertus JA. Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure. J Am Coll Cardiol. 2000; 35(5):1245-1255.
24. Roth DA, McKirnan MD, Canestrelli I, et al. Intracoronary delivery of an adenovirus encoding fibroblast growth factor-4 in myocardial ischemia: effect of serum antibodies and previous exposure to adenovirus. Hum Gene Ther. 2006; 17(2):230-238.
25. Cheng RK, Cox M, Neely ML, et al. Outcomes in patients with heart failure with preserved, borderline, and reduced ejection fraction in the Medicare population. Am Heart J. 2014; 168(5):721-730.
26. Gundersen T, Swedberg K, Amtorp O, Remes J, Nilsson B; Ramipril Study Group. Absence of effect on exercise capacity of 12-weeks treatment with ramipril in patients with moderate congestive heart failure. Eur Heart J. 1994; 15(12):1659-1665.
27. Gullestad L, Manhenke C, Aarsland T, et al. Effect of metoprolol CR/XL on exercise tolerance in chronic heart failure- a substudy to the MERIT-HF trial. Eur J Heart Fail. 2001; 3(4):463-468.
28. Gene Therapy Clinical Trials Worldwide. 2015 Update. J Gene Med. http://www.wiley.co.uk/genmed/clinical. Published 2015. Accessed October 1, 2015.
29. Greenberg B, Yaroshinsky A, Zsebo KM, et al. Design of a phase 2b trial of intracoronary administration of AAV1/SERCA2a in patients with advanced heart failure: the CUPID 2 trial (Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease Phase 2b). JACC Heart Fail. 2014; 2(1):84-92.
30. Greenberg B, Butler J, Felker GM, et al. Calcium upregulation by percutaneous administration of gene therapy in patients with cardiac disease (CUPID 2): a randomised, multinational, double-blind, placebo-controlled, phase 2b trial [published online January 21, 2016]. Lancet.