Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

被引：122

作者：

Solomon, Scott D. ^{[1
]}

Rizkala, Adel R. ^{[2
]}

Lefkowitz, Martin P. ^{[2
]}

Shi, Victor C. ^{[2
]}

Gong, JianJian ^{[2
]}

Anavekar, Nagesh ^{[3
]}

Anker, Stefan D. ^{[4
,5
,6
]}

Arango, Juan L. ^{[7
,8
,9
]}

Arenas, Jose L. ^{[8
]}

Atar, Dan ^{[10
]}

Ben-Gal, Turia ^{[11
]}

Boytsov, Sergey A. ^{[12
]}

Chen, Chen-Huan ^{[13
]}

Chopra, Vijay K. ^{[14
]}

Cleland, John ^{[15
,17
]}

Comin-Colet, Josep ^{[18
,19
]}

Duengen, Hans-Dirk ^{[20
]}

Echeverria Correa, Luis E. ^{[21
,22
]}

Filippatos, Gerasimos ^{[23
,24
]}

Flammer, Andreas J. ^{[25
]}

Galinier, Michel ^{[26
]}

Godoy, Armando ^{[27
,28
,29
]}

Goncalvesova, Eva ^{[30
]}

Janssens, Stefan ^{[31
]}

Katova, Tzvetana ^{[32
]}

Kober, Lars ^{[34
]}

Lelonek, Malgorzata ^{[35
]}

Linssen, Gerard ^{[36
,37
]}

Lund, Lars H. ^{[38
]}

O'Meara, Eileen ^{[39
]}

Merkely, Bela ^{[40
]}

Milicic, Davor ^{[41
]}

Oh, Byung-Hee ^{[42
]}

Perrone, Sergio V. ^{[43
]}

Ranjith, Naresh ^{[44
]}

Saito, Yoshihiko ^{[45
]}

Saraiva, Jose F. ^{[33
]}

Shah, Sanjiv ^{[46
]}

Seferovic, Petar M. ^{[47
]}

Senni, Michele ^{[48
]}

Sibulo, Antonio S., Jr. ^{[49
]}

Sim, David ^{[50
]}

Sweitzer, Nancy K. ^{[51
]}

Taurio, Jyrki ^{[52
]}

Vinereanu, Dragos ^{[53
]}

Vrtovec, Bojan ^{[54
]}

Widimsky, Jiri ^{[55
]}

Yilmaz, Mehmet B. ^{[56
]}

Zhou, Jingmin ^{[57
]}

Zweiker, Robert ^{[58
]}

机构：

[1] Harvard Med Sch, Brigham & Womens Hosp, Cardiovasc Div, Boston, MA 02115 USA

[2] Novartis Pharmaceut, E Hanover, NJ USA

[3] Univ Melbourne, Fac Med Dent & Hlth Sci, Melbourne, Vic, Australia

[4] Charite Univ Med Berlin, Deutsch Zentrum Herz Kreislauf Forsch DZHK Berlin, Div Cardiol & Metab, Dept Cardiol CVK, Berlin, Germany

[5] Charite Univ Med Berlin, Deutsch Zentrum Herz Kreislauf Forsch DZHK Berlin, Berlin Brandenburg Ctr Regenerat Therapies BCRT, Berlin, Germany

[6] Univ Gottingen, Med Ctr, Dept Cardiol & Pneumol, Gottingen, Germany

[7] Guatemalan Heart Inst, San Luis Potosi, Mexico

[8] Ctr Atenc & Invest Cardiovasc Potosi SC, San Luis Potosi, Mexico

[9] Hosp Angeles San Luis, San Luis Potosi, Mexico

[10] Univ Oslo, Dept Cardiol B, Oslo, Norway

[11] Rabin Med Ctr, Cardiol Dept, Heart Failure Unit, Petah Tiqwa, Israel

[12] Minist Hlth Russian Federat, Natl Res Ctr Cardiol, Moscow, Russia

[13] Natl Yang Ming Univ, Dept Med, Taipei, Taiwan

[14] Medanta Med, Heart Failure Unit, Gurugram, Haryana, India

[15] Univ Glasgow, Inst Hlth & Wellbeing, Robertson Ctr Biostat & Clin Trials, Glasgow, Lanark, Scotland

[16] Univ Glasgow, British Heart Fdn, Cardiovasc Res Ctr, Glasgow, Lanark, Scotland

[17] Imperial Coll, Royal Brompton & Harefield Hosp, Natl Heart & Lung Inst, London, England

[18] Univ Barcelona, Bellvitge Univ Hosp, Dept Cardiol, Community Heart Failure Program, Barcelona, Spain

[19] Univ Barcelona, Inst Invest Biomed Bellvitge, Barcelona, Spain

[20] Univ Med Berlin, Cardiol Charite, Dept Internal Med, Campus Virchow Klinikum Berlin, Berlin, Germany

[21] Fdn Cardiovasc Colombia, Heart Failure Unit, Santander, Spain

[22] Fdn Cardiovasc Colombia, Cardiac Transplant Program, Santander, Spain

[23] Natl & Kapodistrian Univ Athens, Attikon Univ Hosp, Athens, Greece

[24] Univ Cyprus, Sch Med, Athens, Greece

[25] Univ Hosp Zurich, Univ Heart Ctr Zurich, Dept Cardiol, Zurich, Switzerland

[26] Rangueil Univ Hosp, Dept Cardiol, Toulouse, France

[27] Univ Nacl Mayor San Marcos, Lima, Peru

[28] Inst Nacl Cardiovasc INCOR, Lima, Peru

[29] Scientia Clin & Epidemiol Res Inst, Trujillo, Peru

[30] Natl Cardiovasc Inst, Dept Heart Failure Transplantat, Bratislava, Slovakia

[31] Univ Hosp Leuven, Dept Cardiol, Leuven, Belgium

[32] Natl Cardiol Hosp, Clin Cardiol, Sofia, Bulgaria

[33] Pontificia Univ Catolica Campinas, Fac Med, Disciplina Cardiol, Sao Paulo, Brazil

[34] Copenhagen Univ Hosp, Rigshosp, Heart Ctr, Dept Cardiol, Copenhagen, Denmark

[35] Med Univ Lodz, Dept Noninvas Cardiol, Lodz, Poland

[36] Hosp Grp Twente, Dept Cardiol, Almelo, Netherlands

[37] Hosp Grp Twente, Dept Cardiol, Hengelo, Netherlands

[38] Karolinska Univ Hosp, Karolinska Inst & Heart & Vasc Theme, Dept Med, Stockholm, Sweden

[39] Univ Montreal, Inst Cardiol Montreal, Montreal, PQ, Canada

[40] Semmelweis Univ, Heart & Vasc Ctr, Budapest, Hungary

[41] Univ Hosp Ctr Zagreb, Dept Cardiovasc Dis, Zagreb, Croatia

[42] Seoul Natl Univ, Seoul Natl Univ Hosp, Coll Med, Seoul, South Korea

[43] Inst FLENI, Buenos Aires, DF, Argentina

[44] City Hosp, Dept Cardiol, Durban, South Africa

[45] Nara Med Univ, Dept Internal Med 1, Kashihara, Nara, Japan

[46] Northwestern Univ, Feinberg Sch Med, Dept Med, Div Cardiol, Chicago, IL 60611 USA

[47] Univ Belgrade, Med Ctr, Univ Belgrade, Dept Cardiol,Sch Med, Belgrade, Serbia

[48] Hosp Papa Giovanni XXIII, Cardiovasc Dept, Cardiol Div, Bergamo, Italy

[49] St Lukes Med Ctr, St Lukes Heart Inst, Taguig, Philippines

[50] Natl Heart Ctr Singapore, Dept Cardiol, Singapore, Singapore

来源：

CIRCULATION-HEART FAILURE | 2018年 / 11卷 / 07期

关键词：

angiotensin receptor antagonists; endopeptidases; heart failure; diastolic; clinical trial; NEPRILYSIN INHIBITION; OUTCOMES;

D O I：

10.1161/CIRCHEARTFAILURE.118.004962

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：10

共 50 条

[1] The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction
Gronda, Edoardo
Vanoli, Emilio
Iacoviello, Massimo
[J]. EUROPEAN HEART JOURNAL SUPPLEMENTS, 2020, 22 (0L) : L77 - L81
[2] Atrial fibrillation in heart failure with preserved ejection fraction - the PARAGON-HF trial
Cikes, M.
Milicic, D.
Planinc, I.
Claggett, B.
Cunningham, J.
Sweitzer, N.
Senni, M.
Linssen, G.
Shah, S.
Pfeffer, M.
Zile, M.
Anand, I.
Chiang, L-M
Mcmurray, J. J. V.
Solomon, S. D.
[J]. EUROPEAN JOURNAL OF HEART FAILURE, 2020, 22 : 13 - 13
[3] Global differences in heart failure with preserved ejection fraction: the paragon-hf trial
Tromp, J.
Clagget, B. L.
Jhund, P.
Kober, L.
Widimsky, J.
Chopra, V
Ge, J.
Maggioni, A. P.
Martinez, F.
Zannad, F.
Lefkowitz, M. P.
Shi, V. C.
McMurray, J. J., V
Solomon, S. D.
Lam, C. S. P.
[J]. EUROPEAN HEART JOURNAL, 2020, 41 : 850 - 850
[4] Global Differences in Heart Failure With Preserved Ejection Fraction The PARAGON-HF Trial
Tromp, Jasper
Claggett, Brian L.
Liu, Jiankang
Jackson, Alice M.
Jhund, Pardeep S.
Kober, Lars
Widimsky, Jiri
Boytsov, Sergey A.
Chopra, Vijay K.
Anand, Inder S.
Ge, Junbo
Chen, Chen-Huan
Maggioni, Aldo P.
Martinez, Felipe
Packer, Milton
Pfeffer, Marc A.
Pieske, Burkert
Redfield, Margaret M.
Rouleau, Jean L.
Van Veldhuisen, Dirk J.
Zannad, Faiez
Zile, Michael R.
Rizkala, Adel R.
Inubushi-Molessa, Akiko
Lefkowitz, Martin P.
Shi, Victor C.
McMurray, John J., V
Solomon, Scott D.
Lam, Carolyn S. P.
[J]. CIRCULATION-HEART FAILURE, 2021, 14 (04) : 468 - 477
[5] Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction The PARAGON-HF Trial
Cikes, Maja
Planinc, Ivo
Claggett, Brian
Cunningham, Jonathan
Milicic, Davor
Sweitzer, Nancy
Senni, Michele
Gori, Mauro
Linssen, Gerard
Shah, Sanjiv J.
Packer, Milton
Pfeffer, Marc
Zile, Michael R.
Anand, Inder
Chiang, Lu-May
Lam, Carolyn S. P.
Redfield, Margaret
Desai, Akshay S.
McMurray, John J. V.
Solomon, Scott D.
[J]. JACC-HEART FAILURE, 2022, 10 (05) : 336 - 346
[6] ABDOMINAL OBESITY AND OUTCOMES IN HEART FAILURE WITH PRESERVED EJECTION FRACTION: THE PARAGON-HF TRIAL
Peikert, Alexander
Vaduganathan, Muthiah
Claggett, Brian
Kulac, Ian
Litwin, Sheldon E.
Zile, Michael R.
Pfeffer, Marc A.
Desai, Akshay S.
Jhund, Pardeep S.
Butt, Jawad Haider
Rouleau, Jean L.
Lefkowitz, Martin
McMurray, John J. V.
Solomon, Scott D.
Packer, Milton
[J]. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2024, 83 (13) : 361 - 361
[7] Age-Related Echocardiographic Characteristics in Patients With Heart Failure With Preserved Ejection Fraction in PARAGON-HF
Wang, Xiaowen
Skali, Hicham
Cikes, Maja
Vardeny, Orly
Lam, Carolyn S.
Redfield, Margaret M.
Kosztin, Annamaria
Omeara, Eileen
Mullens, Wilfried
McMurray, John J.
Shah, Amil M.
Solomon, Scott
Hegde, Sheila
[J]. CIRCULATION, 2023, 148
[8] Mode of Death in Patients With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF Trial
Desai, Akshay S.
Vaduganathan, Muthiah
Cleland, John G.
Claggett, Brian L.
Barkoudah, Ebrahim
Finn, Peter
McCausland, Finnian R.
Yilmaz, Mehmet B.
Lefkowitz, Martin
Shi, Victor
Pfeffer, Marc A.
McMurray, John J. V.
Solomon, Scott D.
[J]. CIRCULATION-HEART FAILURE, 2021, 14 (12) : 1283 - 1290
[9] Eligibility of patients with heart failure with preserved ejection fraction for sacubitril/valsartan according to the PARAGON-HF trial
Lund, Lars H.
Savarese, Gianluigi
Venkateshvaran, Ashwin
Benson, Lina
Lundberg, Anna
Donal, Erwan
Daubert, Jean-Claude
Oger, Emmanuel
Linde, Cecilia
Hage, Camilla
[J]. ESC HEART FAILURE, 2022, 9 (01): : 164 - 177
[10] Determinants of Right Ventricular Dysfunction in Patients With Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial Experience
Lu, Henri
Inciardi, Riccardo M.
Abanda, Martin
Shah, Amil M.
Cikes, Maja
Claggett, Brian
Prasad, Narayana
Lam, Carolyn S.
Redfield, Margaret M.
McMurray, John J.
Solomon, Scott
Hegde, Sheila
Skali, Hicham
[J]. CIRCULATION, 2023, 148

← 1 2 3 4 5 →