1. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial
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Faiez Zannad, Andreas J. Flammer, Lars Køber, Yoshihiko Saito, Inder S. Anand, Turia Ben-Gal, Adel R. Rizkala, Davor Miličić, Hans Dirk Duengen, Nancy K. Sweitzer, Junbo Ge, Jiří Widimský, Tzvetana Katova, Robert Zweiker, Chen Huan Chen, Sergio V. Perrone, Margaret M. Redfield, Sanjiv J. Shah, Michael R. Zile, Milton Packer, Jean L. Rouleau, Felipe Martinez, Michele Senni, Juan Luis Arango, Gerard Linssen, Eileen O'Meara, Vijay K. Chopra, Aldo P. Maggioni, Josep Comín-Colet, Bojan Vrtovec, Stefan D. Anker, Jyrki Taurio, Armando Godoy, Scott D. Solomon, Jingmin Zhou, David Sim, Małgorzata Lelonek, Dragos Vinereanu, Michel Galinier, John J.V. McMurray, Carolyn S.P. Lam, Naresh Ranjith, Burkert Pieske, Nagesh S. Anavekar, Béla Merkely, Jose L. Arenas, Sergey Boytsov, John G.F. Cleland, José Francisco Kerr Saraiva, Stefan Janssens, Jianjian Gong, Victor Shi, Dirk J. van Veldhuisen, Eva Goncalvesova, Antonio S. Sibulo, Petar M. Seferovic, Martin Lefkowitz, Byung Hee Oh, Mehmet Yilmaz, Luis E. Echeverría Correa, Marc A. Pfeffer, Lars Lund, Dan Atar, Gerasimos Filippatos, Cardiovascular Centre (CVC), Solomon, S, Rizkala, A, Lefkowitz, M, Shi, V, Gong, J, Anavekar, N, Anker, S, Arango, J, Arenas, J, Atar, D, Ben-Gal, T, Boytsov, S, Chen, C, Chopra, V, Cleland, J, Comin-Colet, J, Duengen, H, Echeverria Correa, L, Filippatos, G, Flammer, A, Galinier, M, Godoy, A, Goncalvesova, E, Janssens, S, Katova, T, Kober, L, Lelonek, M, Linssen, G, Lund, L, O'Meara, E, Merkely, B, Milicic, D, Oh, B, Perrone, S, Ranjith, N, Saito, Y, Saraiva, J, Shah, S, Seferovic, P, Senni, M, Sibulo, A, Sim, D, Sweitzer, N, Taurio, J, Vinereanu, D, Vrtovec, B, Widimsky, J, Yilmaz, M, Zhou, J, Zweiker, R, Anand, I, Ge, J, Lam, C, Maggioni, A, Martinez, F, Packer, M, Pfeffer, M, Pieske, B, Redfield, M, Rouleau, J, Van Veldhuisen, D, Zannad, F, Zile, M, Mcmurray, J, [Solomon, Scott D. -- Pfeffer, Marc A.] Harvard Med Sch, Brigham & Womens Hosp, Cardiovasc Div, Boston, MA 02115 USA -- [Rizkala, Adel R. -- Lefkowitz, Martin P. -- Shi, Victor C. -- Gong, JianJian] Novartis Pharmaceut, E Hanover, NJ USA -- [Anavekar, Nagesh] Univ Melbourne, Fac Med Dent & Hlth Sci, Melbourne, Vic, Australia -- [Anker, Stefan D.] Charite Univ Med Berlin, Deutsch Zentrum Herz Kreislauf Forsch DZHK Berlin, Div Cardiol & Metab, Dept Cardiol CVK, Berlin, Germany -- [Anker, Stefan D.] Charite Univ Med Berlin, Deutsch Zentrum Herz Kreislauf Forsch DZHK Berlin, Berlin Brandenburg Ctr Regenerat Therapies BCRT, Berlin, Germany -- [Anker, Stefan D.] Univ Gottingen, Med Ctr, Dept Cardiol & Pneumol, Gottingen, Germany -- [Arango, Juan L.] Guatemalan Heart Inst, San Luis Potosi, Mexico -- [Arango, Juan L.] Ctr Atenc & Invest Cardiovasc Potosi SC, San Luis Potosi, Mexico -- [Arango, Juan L.] Hosp Angeles San Luis, San Luis Potosi, Mexico -- [Atar, Dan] Univ Oslo, Dept Cardiol B, Oslo, Norway -- [Ben-Gal, Turia] Rabin Med Ctr, Cardiol Dept, Heart Failure Unit, Petah Tiqwa, Israel -- [Boytsov, Sergey A.] Minist Hlth Russian Federat, Natl Res Ctr Cardiol, Moscow, Russia -- [Chen, Chen-Huan] Natl Yang Ming Univ, Dept Med, Taipei, Taiwan -- [Chopra, Vijay K.] Medanta Med, Heart Failure Unit, Gurugram, Haryana, India -- [Cleland, John] Univ Glasgow, Inst Hlth & Wellbeing, Robertson Ctr Biostat & Clin Trials, Glasgow, Lanark, Scotland -- [McMurray, John J. V.] Univ Glasgow, British Heart Fdn, Cardiovasc Res Ctr, Glasgow, Lanark, Scotland -- [Cleland, John] Imperial Coll, Royal Brompton & Harefield Hosp, Natl Heart & Lung Inst, London, England -- [Comin-Colet, Josep] Univ Barcelona, Bellvitge Univ Hosp, Dept Cardiol, Community Heart Failure Program, Barcelona, Spain -- [Comin-Colet, Josep] Univ Barcelona, Inst Invest Biomed Bellvitge, Barcelona, Spain -- [Duengen, Hans-Dirk -- Pieske, Burkert] Univ Med Berlin, Cardiol Charite, Dept Internal Med, Campus Virchow Klinikum Berlin, Berlin, Germany -- [Echeverria Correa, Luis E.] Fdn Cardiovasc Colombia, Heart Failure Unit, Santander, Spain -- [Echeverria Correa, Luis E.] Fdn Cardiovasc Colombia, Cardiac Transplant Program, Santander, Spain -- [Filippatos, Gerasimos] Univ Athens, Attikon Univ Hosp, Athens, Greece -- [Filippatos, Gerasimos] Univ Cyprus, Sch Med, Athens, Greece -- [Flammer, Andreas J.] Univ Hosp Zurich, Univ Heart Ctr Zurich, Dept Cardiol, Zurich, Switzerland -- [Galinier, Michel] Rangueil Univ Hosp, Dept Cardiol, Toulouse, France -- [Godoy, Armando] Univ Nacl Mayor San Marcos, Lima, Peru -- [Godoy, Armando] Inst Nacl Cardiovasc INCOR, Lima, Peru -- [Godoy, Armando] Scientia Clin & Epidemiol Res Inst, Trujillo, Peru -- [Goncalvesova, Eva] Natl Cardiovasc Inst, Dept Heart Failure Transplantat, Bratislava, Slovakia -- [Janssens, Stefan] Univ Hosp Leuven, Dept Cardiol, Leuven, Belgium -- [Katova, Tzvetana] Natl Cardiol Hosp, Clin Cardiol, Sofia, Bulgaria -- [Saraiva, Jose F.] Pontificia Univ Catolica Campinas, Fac Med, Disciplina Cardiol, Sao Paulo, Brazil -- [Kober, Lars] Copenhagen Univ Hosp, Rigshosp, Heart Ctr, Dept Cardiol, Copenhagen, Denmark -- [Lelonek, Malgorzata] Med Univ Lodz, Dept Noninvas Cardiol, Lodz, Poland -- [Linssen, Gerard] Hosp Grp Twente, Dept Cardiol, Almelo, Netherlands -- [Linssen, Gerard] Hosp Grp Twente, Dept Cardiol, Hengelo, Netherlands -- [Lund, Lars H.] Karolinska Univ Hosp, Karolinska Inst & Heart & Vasc Theme, Dept Med, Stockholm, Sweden -- [O'Meara, Eileen -- Rouleau, Jean L.] Univ Montreal, Inst Cardiol Montreal, Montreal, PQ, Canada -- [Merkely, Bela] Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary -- [Milicic, Davor] Univ Hosp Ctr Zagreb, Dept Cardiovasc Dis, Zagreb, Croatia -- [Oh, Byung-Hee] Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Seoul, South Korea -- [Perrone, Sergio V.] Inst FLENI, Buenos Aires, DF, Argentina -- [Ranjith, Naresh] City Hosp, Dept Cardiol, Durban, South Africa -- [Saito, Yoshihiko] Nara Med Univ, Dept Internal Med 1, Kashihara, Nara, Japan -- [Shah, Sanjiv] Northwestern Univ, Feinberg Sch Med, Dept Med, Div Cardiol, Chicago, IL 60611 USA -- [Seferovic, Petar M.] Univ Belgrade, Med Ctr, Univ Belgrade, Dept Cardiol,Sch Med, Belgrade, Serbia -- [Senni, Michele] Hosp Papa Giovanni XXIII, Cardiovasc Dept, Cardiol Div, Bergamo, Italy -- [Sibulo, Antonio S., Jr.] St Lukes Med Ctr, St Lukes Heart Inst, Taguig, Philippines -- [Sim, David] Natl Heart Ctr Singapore, Dept Cardiol, Singapore, Singapore -- [Sweitzer, Nancy K.] Univ Arizona, Coll Med, Sarver Heart Ctr, Tucson, AZ USA -- [Taurio, Jyrki] Tampere Univ Hosp, Dept Cardiol, Tampere, Finland -- [Vinereanu, Dragos] Univ Med & Pharm Carol Davila, Univ & Emergency Hosp Bucharest, Bucharest, Romania -- [Vrtovec, Bojan] Univ Med Ctr, Ljubljana, Slovenia -- [Widimsky, Jiri] Charles Univ Prague, Fac Med 1, Prague, Czech Republic -- [Yilmaz, Mehmet B.] Cumhuriyet Univ, Fac Med, Dept Cardiol, Sivas, Turkey -- [Zhou, Jingmin] Tongji Univ, Sch Med, Tongji Hosp, Dept Cardiol, Shanghai, Peoples R China -- [Zweiker, Robert] Med Univ Graz, Dept Cardiol, Graz, Austria -- [Anand, Inder S.] VA Med Ctr, Dept Med, Minneapolis, MN USA -- [Anand, Inder S.] Univ Minnesota, Minneapolis, MN USA -- [Ge, Junbo] Fudan Univ, Zhongshan Hosp, Shanghai Inst Cardiovasc Dis, Shanghai, Peoples R China -- [Lam, Carolyn S. P.] Natl Heart Ctr Singapore, Singapore, Singapore -- [Lam, Carolyn S. P.] Duke Natl Univ Singapore, Singapore, Singapore -- [Maggioni, Aldo P.] Associaz Nazl Med Cardiol Osped, Florence, Italy -- [Martinez, Felipe] Univ Nacl Cordoba, Cordoba, Argentina -- [Packer, Milton] Baylor Univ, Med Ctr, Baylor Heart & Vasc Inst, Dallas, TX USA -- [Redfield, Margaret M.] Mayo Clin, Dept Cardiovasc Med, Rochester, MN USA -- [Van Veldhuisen, Dirk J.] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands -- [Zannad, Faiez] INSERM, CIC 1433, Nancy, France -- [Zannad, Faiez] Univ Lorraine, CHR Univ, Nancy, France -- [Zile, Michael R.] Med Univ South Carolina, Charleston, SC 29425 USA -- [Zile, Michael R.] Ralph H Johnson Vet Adm, Med Ctr, Charleston, SC USA, Boytsov, Sergey -- 0000-0001-6998-8406, Maggioni, Aldo Pietro -- 0000-0003-2764-6779, and Anand, Inder -- 0000-0003-1308-4963
- Subjects
Male ,medicine.medical_specialty ,Angiotensin receptor ,Adrenergic beta-Antagonists ,Diastole ,heart failure ,Angiotensin-Converting Enzyme Inhibitors ,030204 cardiovascular system & hematology ,heart failure, diastolic ,Ventricular Function, Left ,03 medical and health sciences ,NEPRILYSIN INHIBITION ,0302 clinical medicine ,Internal medicine ,angiotensin receptor antagonists ,Medicine ,Humans ,030212 general & internal medicine ,10. No inequality ,endopeptidase ,Aged ,Mineralocorticoid Receptor Antagonists ,Aged, 80 and over ,antagonists ,Clinical Trials as Topic ,OUTCOMES ,Ejection fraction ,Angiotensin Receptor Antagonists ,business.industry ,Stroke Volume ,clinical trial ,Middle Aged ,angiotensin receptor ,medicine.disease ,3. Good health ,Clinical trial ,endopeptidases ,angiotensin receptor antagonist ,diastolic ,Baseline characteristics ,Heart failure ,Cardiology ,Valsartan ,Female ,Cardiology and Cardiovascular Medicine ,business ,Angiotensin II Type 1 Receptor Blockers - Abstract
WOS: 000438926500008, PubMed ID: 29980595, BACKGROUND: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality. METHODS AND RESULTS: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7 +/- 8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had >= 1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), beta-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease. CONCLUSIONS: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics., Novartis, The PARAGON-HF trial is funded by Novartis.
- Published
- 2018