CVCT Publications
Introduction
Over the last decade, an Early Career Writing Group has worked to capture the rich dialogue at CVCT Sessions. Typically, early career investigators are paired with senior mentors and leaders in cardiovascular medicine to construct an enduring document summarizing a focused topic discussed at CVCT. These manuscripts aim to challenge the current concepts and point towards future directions of research. If you have interest in writing one of these manuscripts, please send a half-page proposal/outline to the Writing Group chairs.
Editorial Coordinators
In order to participate in our writing group, get in touch with us here
2023
Rapid, accurate publication and dissemination of clinical trial results: benefits and challenges (Eur Heart J 2023)
Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives
https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2828
2022
How can we optimise health technology assessment and reimbursement decisions to accelerate access to new cardiovascular medicines? (Int J Cardiol 2022)
https://www.internationaljournalofcardiology.com/action/showPdf?pii=S0167-5273%2822%2901089-0
2021
https://www.jacc.org/doi/abs/10.1016/j.jacc.2021.04.038
The expert guide to becoming a cardiovascular clinical trialist (Eur Heart J 2021)
https://academic.oup.com/eurheartj/article/42/29/2810/6177054
Patient partnership in cardiovascular clinical trials (Eur Heart J 2021)
https://academic.oup.com/eurheartj/article-abstract/43/14/1432/6460258?redirectedFrom=fulltext
The Future of Meat: Health Impact Assessment with Randomized Evidence.
Ferreira JP, Sharma A, Zannad F.Am J Med. 2021 May;134(5):569-575.
The Decline of the Experimental Paradigm During the COVID-19 Pandemic: A Template for the Future.
Ferreira JP, Epstein M, Zannad F.Am J Med. 2021 Feb;134(2):166-175
What can heart failure trialists learn from oncology trialists?
Faiez Zannad, Gad Cotter, Angeles Alonso Garcia, Suzanne George, Beth Davison, Gemma Figtree, Krishna Prasad, Frank Rockhold, Richard L Schilsky, Norman Stockbridge, Bertram Pitt, Javed Butler
European Heart Journal, June 2021
https://academic.oup.com/eurheartj/article-abstract/42/24/2373/6291019?redirectedFrom=fulltext
2020
Challenges of Cardio-kidney Composite Outcomes in Large-Scale Clinical Trials
Patel RB, te Maaten J, Ferreira JP, McCausland F, Shah SJ, Rossignol P, Solomon SD, Vaduganathan M, Packer M, Thompson A, Stockbridge N, Zannad F.
Circulation 2020
Improving the Design of Future PCI Trials for Stable Coronary Artery Disease: JACC State-of-the-Art Review
Guillaume Marquis-Gravel, David J. Moliterno, Darrel P. Francis, Peter Jüni, Yves D. Rosenberg, Bimmer E. Claessen, Robert J. Mentz, Roxana Mehran, Donald E. Cutlip, Cynthia Chauhan, Susan Quella, Faiez Zannad, and Shaun G. Goodman.
JACC 2020
https://www.jacc.org/doi/full/10.1016/j.jacc.2020.05.060
Abnormalities of Potassium in Heart Failure: JACC State-of-the-Art Review.
Ferreira JP, Butler J, Rossignol P, Pitt B, Anker SD, Kosiborod M, Lund LH, Bakris GL, Weir MR, Zannad F.J Am Coll Cardiol. 2020 Jun 9;75(22):2836-2850
2019
Abnormalities of Potassium in Heart Failure
João Pedro Ferreira, Javed Butler, Patrick Rossignol, Bertram Pitt, Stefan D. Anker, Mikhail Kosiborod, Lars H. Lund, George L. Bakris, Matthew R. Weir and Faiez Zannad
Journal of the American College of Cardiology Volume 75, Issue 22, June 2020
2018
Antihyperglycemic Therapies to Treat Patients With Heart Failure and Diabetes Mellitus. Sharma A, Cooper LB, Fiuzat M, Mentz RJ, Ferreira JP, Butler J, Fitchett D, Moses AC, O'Connor C, Zannad F. JACC Heart Fail. 2018 Oct;6(10):813-822
Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure. Greene SJ, Mentz RJ, Fiuzat M, Butler J, Solomon SD, Ambrosy AP, Mehta C, Teerlink JR, Zannad F, O'Connor CM. Circulation. 2018 Sep 4;138(10):1039-1053.
The role of angiotensin receptor-neprilysin inhibitors in cardiovascular disease-existing evidence, knowledge gaps, and future directions. Ambrosy AP, Mentz RJ, Fiuzat M, Cleland JGF, Greene SJ, O'Connor CM, Teerlink JR, Zannad F, Solomon SD. Eur J Heart Fail. 2018 Jun;20(6):963-972.
Evolution of natriuretic peptide biomarkers in heart failure: Implications for clinical care and clinical trials. Vodovar N, Mebazaa A, Januzzi JL Jr, Murtagh G, Stough WG, Adams KF Jr, Zannad F. Int J Cardiol. 2018 Mar 1;254:215-221
2017
Role of Payers in the Development of Cardiovascular Therapeutics: Misalignment Between Approval and Reimbursement. Zannad F, Alonso Garcia MLA, Borer JS, Stough WG, Clutton-Brock T, Rosenberg Y, Packer M. J Am Coll Cardiol. 2017 Dec 5;70(22):2822-2830.
Tailoring mineralocorticoid receptor antagonist therapy in heart failure patients: are we moving towards a personalized approach? Ferreira JP, Mentz RJ, Pizard A, Pitt B, Zannad F. Eur J Heart Fail. 2017 Aug;19(8):974-986.
Declining Risk of Sudden Death in Heart Failure. Shen L, Jhund PS, Petrie MC, Claggett BL, Barlera S, Cleland JGF, Dargie HJ, Granger CB, Kjekshus J, Køber L, Latini R, Maggioni AP, Packer M, Pitt B, Solomon SD, Swedberg K, Tavazzi L, Wikstrand J, Zannad F, Zile MR, McMurray JJV. N Engl J Med. 2017 Jul 6;377(1):41-51
The burden of proof: The current state of atrial fibrillation prevention and treatment trials. Zakeri R, Van Wagoner DR, Calkins H, Wong T, Ross HM, Heist EK, Meyer TE, Kowey PR, Mentz RJ, Cleland JG, Pitt B, Zannad F, Linde C. Heart Rhythm. 2017 May;14(5):763-782.
Declining Risk of Sudden Death in Heart Failure
Streamlining cardiovascular clinical trials to improve efficiency and generalisability. Zannad F, Pfeffer MA, Bhatt DL, Bonds DE, Borer JS, Calvo-Rojas G, Fiore L, Lund LH, Madigan D, Maggioni AP, Meyers CM, Rosenberg Y, Simon T, Stough WG, Zalewski A, Zariffa N, Temple R. Heart. 2017 Apr 28
Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints. Rossignol P, Agarwal R, Canaud B, Charney A, Chatellier G, Craig JC, Cushman WC, Gansevoort RT, Fellström B, Garza D, Guzman N, Holtkamp FA, London GM, Massy ZA, Mebazaa A, Mol PGM, Pfeffer MA, Rosenberg Y, Ruilope LM, Seltzer J, Shah AM, Shah S, Singh B, Stefánsson BV, Stockbridge N, Stough WG, Thygesen K, Walsh M, Wanner C, Warnock DG, Wilcox CS, Wittes J, Pitt B, Thompson A, Zannad F. Eur Heart J. 2017 Apr 18
2016
Emergency management of severe hyperkalemia: Guideline for best practice and opportunities for the future. Rossignol P, Legrand M, Kosiborod M, Hollenberg SM, Peacock WF, Emmett M, Epstein M, Kovesdy CP, Yilmaz MB, Stough WG, Gayat E, Pitt B, Zannad F, Mebazaa A. Pharmacol Res. 2016 Nov;113(Pt A):585-591
New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval. Zannad F, Rossignol P, Stough WG, Epstein M, Alonso Garcia Mde L, Bakris GL, Butler J, Kosiborod M, Berman L, Mebazaa A, Rasmussen HS, Ruilope LM, Stockbridge N, Thompson A, Wittes J, Pitt B. Int J Cardiol. 2016 Aug 1;216:46-51. doi: 10.1016/j.ijcard.2016.04.127. Epub 2016 Apr 19.
Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment versus risk aversion. Zannad F, Stough WG, Lipicky RJ, Tamargo J, Bakris GL, Borer JS, Alonso García Mde L, Hadjadj S, Koenig W, Kupfer S, McCullough PA, Mosenzon O, Pocock S, Scheen AJ, Sourij H, Van der Schueren B, Stahre C, White WB, Calvo G. Eur Heart J Cardiovasc Pharmacother. 2016 Jul;2(3):200-5
Heart Failure Clinical Trials in East and Southeast Asia: Understanding the Importance and Defining the Next Steps. Mentz RJ, Roessig L, Greenberg BH, Sato N, Shinagawa K, Yeo D, Kwok BW, Reyes EB, Krum H, Pieske B, Greene SJ, Ambrosy AP, Kelly JP, Zannad F, Pitt B, Lam CS. JACC Heart Fail. 2016 Jun;4(6):419-27
Neural modulation for hypertension and heart failure. Smith S, Rossignol P, Willis S, Zannad F, Mentz R, Pocock S, Bisognano J, Nadim Y, Geller N, Ruble S, Linde C.Int J Cardiol. 2016 Jul 1;214:320-30.
2015
Cardiac resynchronization therapy in heart failure patients with less severe left ventricular dysfunction. Hai OY, Mentz RJ, Zannad F, Gasparini M, De Ferrari GM, Daubert JC, Holzmeister J, Lam CS, Pochet T, Vincent A, Linde C Eur J Heart Fail. 2015 Feb;17(2):135-43. doi: 10.1002/ejhf.208. Epub 2014 Dec 3. .
Patient selection in heart failure with preserved ejection fraction clinical trials. Kelly JP, Mentz RJ, Mebazaa A, Voors AA, Butler J, Roessig L, Fiuzat M, Zannad F, Pitt B, O'Connor CM, Lam CS J Am Coll Cardiol. 2015 Apr 28;65(16):1668-82. doi: 10.1016/j.jacc.2015.03.043.
Atherosclerosis: Recent trials, new targets and future directions. Ladeiras-Lopes R, Agewall S, Tawakol A, Staels B, Stein E, Mentz RJ, Leite-Moreira A, Zannad F, Koenig W Int J Cardiol. 2015 Aug 1;192:72-81. doi: 10.1016/j.ijcard.2015.05.013. Epub 2015 May 8. Review.
Agents with vasodilator properties in acute heart failure: how to design successful trials. Mebazaa A, Longrois D, Metra M, Mueller C, Richards AM, Roessig L, Seronde MF, Sato N, Stockbridge N, Gattis Stough W, Alonso A, Cody R, Cook Bruns N, Gheorghiade M, Holzmeister J, Laribi S, Zannad F European Journal of Heart Failure (2015) 17, 652–664 doi:10.1002/ejhf.294. Review .
Cardiac resynchronization therapy in heart failure patients with less severe left ventricular dysfunction. Hai OY, Mentz RJ, Zannad F, Gasparini M, De Ferrari GM, Daubert JC, Holzmeister J, Lam CS, Pochet T, Vincent A, Linde C.
Eur J Heart Fail. 2015 Feb;17(2):135-43. doi: 10.1002/ejhf.208. Epub 2014 Dec 3.
Patient selection in heart failure with preserved ejection fraction clinical trials. Kelly JP, Mentz RJ, Mebazaa A, Voors AA, Butler J, Roessig L, Fiuzat M, Zannad F, Pitt B, O'Connor CM, Lam CS.
J Am Coll Cardiol. 2015 Apr 28;65(16):1668-82. doi: 10.1016/j.jacc.2015.03.043.
Atherosclerosis: Recent trials, new targets and future directions. Ladeiras-Lopes R, Agewall S, Tawakol A, Staels B, Stein E, Mentz RJ, Leite-Moreira A, Zannad F, Koenig W.
Int J Cardiol. 2015 Aug 1;192:72-81. doi: 10.1016/j.ijcard.2015.05.013. Epub 2015 May 8. Review.
Design Considerations for Clinical Trials of Autonomic Modulation Therapies Targeting Hypertension and Heart Failure. Zannad F, Stough WG, Mahfoud F, Bakris GL, Kjeldsen SE, Kieval RS, Haller H, Yared N, De Ferrari GM, Piña IL, Stein K, Azizi M. Hypertension. 2015 Jan;65(1):5-15
2014
Time to retrieve the best benefits from renin angiotensin aldosterone system (RAAS) inhibition in heart failure patients with reduced ejection fraction: lessons from randomized controlled trials and registries. Rossignol P, Zannad F, Pitt B; Writing group of 10th Global Cardio Vascular Clinical Trialist forum held on December 6th-7th 2013 in Paris, France.. Int J Cardiol. 2014 Dec 20;177(3):731-3
Noncardiac comorbidities in heart failure with reduced versus preserved ejection fraction. Mentz RJ, Kelly JP, von Lueder TG, Voors AA, Lam CS, Cowie MR, Kjeldsen K, Jankowska EA, Atar D, Butler J, Fiuzat M, Zannad F, Pitt B, O'Connor CM J Am Coll Cardiol. 2014 Dec 2;64(21):2281-93. doi: 10.1016/j.jacc.2014.08.036. Epub 2014 Nov 24. Review.
Current challenges for clinical trials of cardiovascular medical devices.
Zannad F, Stough WG, Piña IL, Mehran R, Abraham WT, Anker SD, De Ferrari GM, Farb A, Geller NL, Kieval RS, Linde C, Redberg RF, Stein K, Vincent A, Woehrle H, Pocock SJ. Int J Cardiol. 2014 Jul 15;175(1):30-7.
http://dx.doi.org/10.1016/j.ijcard.2014.05.021
Trials of implantable monitoring devices in heart failure: which design is optimal?
Abraham WT, Stough WG, Piña IL, Linde C, Borer JS, De Ferrari GM, Mehran R, Stein KM, Vincent A, Yadav JS, Anker SD, Zannad F. Nat Rev Cardiol. 2014 Oct;11(10):576-85. Nature Reviews Cardiology 2014 doi:10.1038/nrcardio.2014.114
Charting a Roadmap for Heart Failure Biomarker Studies
Ahmad T, Fiuzat M, Pencina MJ, Geller NL, Zannad F, Cleland JG, Snider JV, Blankenberg S, Adams KF, Redberg RF, Kim JB, Mascette A, Mentz RJ, O’Connor CM, Felker GM, Januzzi JL. JACC Heart Fail. 2014 Oct;2(5):477-488.
Decongestion in acute heart failure.
Mentz RJ, Kjeldsen K, Rossi GP, Voors AA, Cleland JG, Anker SD, Gheorghiade M, Fiuzat M, Rossignol P, Zannad F, Pitt B, O’Connor C, Felker GM. Eur J Heart Fail. 2014 May;16(5):471-82.
Heart rate: a prognostic factor and therapeutic target in chronic heart failure. The distinct roles of drugs with heart rate-lowering properties.
Dobre D, Borer JS, Fox K, Swedberg K, Adams KF, Cleland JG, Cohen-Solal A, Gheorghiade M, Gueyffier F, O’Connor CM, Fiuzat M, Patak A, Piña IL, Rosano G, Sabbah HN, Tavazzi L, Zannad F. Eur J Heart Fail. 2014 Jan;16(1):76-85.
2013
Learning from recent trials and shaping the future of acute heart failure trials.
Mentz RJ, Felker GM, Ahmad T, Peacock WF, Pitt B, Fiuzat M, Maggioni AP, Gheorghiade M, Ando Y, Pocock SJ, Zannad F, O’Connor CM. Am Heart J. 2013 Oct;166(4):629-35.
Biomarker-guided therapies in heart failure: a forum for unified strategies.
Fiuzat M, O’Connor CM, Gueyffier F, Mascette AM, Geller NL, Mebazaa A, Voors AA, Adams KF, Piña IL, Neyses L, Muntendam P, Felker GM, Pitt B, Zannad F, Bristow MR. J Card Fail. 2013 Aug;19(8):592-9.
The past, present and future of renin-angiotensin aldosterone system inhibition.
Mentz RJ, Bakris GL, Waeber B, McMurray JJ, Gheorghiade M, Ruilope LM, Maggioni AP, Swedberg K, Piña IL, Fiuzat M, O’Connor CM, Zannad F, Pitt B. Int J Cardiol. 2013 Sep 1;167(5):1677-87.
2012
Prevention of cardiovascular disease guided by total risk estimations--challenges and opportunities for practical implementation: highlights of a CardioVascular Clinical Trialists (CVCT) Workshop of the ESC Working Group on CardioVascular Pharmacology and Drug Therapy. Zannad F, Dallongeville J, Macfadyen RJ, Ruilope LM, Wilhelmsen L, De Backer G, Graham I, Lorenz M, Mancia G, Morrow DA, Reiner Z, Koenig W; ESC Working Group on CardioVascular Pharmacology and Drug Therapy.
Implications of geographical variation on clinical outcomes of cardiovascular trials.
Mentz RJ, Kaski JC, Dan GA, Goldstein S, Stockbridge N, Alonso-Garcia A, Ruilope LM, Martinez FA, Zannad F, Pitt B, Fiuzat M, O’Connor CM. Am Heart J. 2012 Sep;164(3):303-12.
2008
Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval. Borer JS1, Pouleur H, Abadie E, Follath F, Wittes J, Pfeffer MA, Pitt B, Zannad F. Eur Heart J. 2007 Aug;28(15):1904-9.European Heart Journal 2007;28:1904-1909.
Globalization of cardiovascularclinical research: the balance between meeting medical needs and maintaining scientific standards. Stough WG1, Zannad F, Pitt B, Goldstein S. Am Heart J. 2007 Aug;154(2):232-8. American Heart Journal 2007;154:232-8
Heart failure as an endpoint in heart failure and non-heart failure cardiovascular clinical trials: the need for a consensus definition. Zannad F, Stough WG, Pitt B, Cleland JG, Adams KF, Geller NL, Torp-Pedersen C, Kirwan BA, Follath F. Eur Heart J 2008;29:413-21.
Similarities and differences in design considerations for cell therapy and pharmacologic cardiovascular clinical trials. Lewis RM, Gordon DJ, Poole-Wilson PA, Borer JS, Zannad F. Cardiology. Cardiology 2008;110:73-80
2006
Borer JS, Gordon DJ, Geller NL. When should data and safety monitoring committees share interim results in cardiovascular trials? JAMA. 2008 Apr 9; 299(14):1710-2.
J Cohn , JGF Cleland, J Lubsen , JS Borer, PG Steg , M Perelman, F Zannad : Unconventional endpoints in cardiovascular clinical trials: should we be moving away from morbidity and mortality? J Card Fail. 2009 Apr; 15(3):199-205
2005
RM Lewis, DJ Gordon, PA Poole-Wilson, JS Borer, F Zannad : Similarities and Differences in Design Considerations for Cell Therapy and Pharmacology Clinical Trials in Cardiovascular Indications. Cardiol 2008; 110:73-80.
W Gattis Stough, F Zannad, B Pitt, S Goldstein : Globalization of Cardiovascular Clinical Research : The Balance Between Meeting Medical Needs and Maintaining Scientific Standards. Am Heart J, August 2007; 154:232-8.
F Zannad, W Gattis Stough, JGF Cleland, NL Geller, C Torp-Pedersen, BA Kirwan, B Pitt, F Follath : Heart Failure as an Endpoint in Heart Failure and Non Heart Failure CardioVascular Clinical Trials : The Need for a Consensus Definition. Eur Heart J. 2008 Feb; 29(3):413-421.
JS Borer, H Pouleur, E Abadie, F Follath, J Wittes, MA. Pfeffer, B Pitt, and F Zannad : Cardiovascular safety of drugs not intended for cardiovascular use: need for a new conceptual basis for assessment and approval. Eur Heart J (2007) 28, 1904–1909.
2004
P Sleight, H Pouleur, and F Zannad : Benefits, Challenges, and registerability of the polypill. Eur H J (2006) 27, 1651-1656.
SM Haffner, L Ruilope, B Dahlöf, E Abadie, S Kupfer, and F Zannad : Metabolic Syndrome, New Onset Diabetes, and New Endpoints in Cardiovascular Trials. Cardiovasc Pharmacol volume 47, Number 3, March 2006.
2002
AP Maggioni, B Darne, D Atar, E Abadie, B Pitt, F Zannad, on behalf of the participants in the 5th CardioVascular Clinical Trialists Workshop : FDA and CPMP Rulings on Subgroup Analyses. Cardiology 2007; 107:97-102.
R Shah, B Darne, D Atar, E Abadie, KF Adams, F Zannad, on behalf of the participants in the 5th CardioVascular Clinical Trialists Workshop : Pharmacogenomics in cardiovascular clinical trials. Fundamental & Clinical Pharmacology 18 (2004) 705-708.