Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial

Scott D. Solomon; Adel R. Rizkala; Martin P. Lefkowitz; Victor C. Shi; Jianjian Gong; Nagesh Anavekar; Stefan D. Anker; Juan L. Arango; Jose L. Arenas; Dan Atar; Turia Ben-Gal; Sergey A. Boytsov; Chen Huan Chen; Vijay K. Chopra; John Cleland; Josep Comin-Colet; Hans Dirk Duengen; Luis E. Echeverría Correa; Gerasimos Filippatos; Andreas J. Flammer; Michel Galinier; Armando Godoy; Eva Goncalvesova; Stefan Janssens; Tzvetana Katova; Lars Køber; Małgorzata Lelonek; Gerard Linssen; Lars H. Lund; Eileen O'Meara; Béla Merkely; Davor Milicic; Byung Hee Oh; Sergio V. Perrone; Naresh Ranjith; Yoshihiko Saito; Jose F. Saraiva; Sanjiv Shah; Petar M. Seferovic; Michele Senni; Antonio S. Sibulo; David Sim; Nancy K. Sweitzer; Jyrki Taurio; Dragos Vinereanu; Bojan Vrtovec; Jiří Widimský; Mehmet B. Yilmaz; Jingmin Zhou; Robert Zweiker; Inder S. Anand; Junbo Ge; Carolyn S.P. Lam; Aldo P. Maggioni; Felipe Martinez; Milton Packer; Marc A. Pfeffer; Burkert Pieske; Margaret M. Redfield; Jean L. Rouleau; Dirk J. Van Veldhuisen; Faiez Zannad; Michael R. Zile; John J.V. McMurray

doi:10.1161/CIRCHEARTFAILURE.118.004962

Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial

Scott D. Solomon, Adel R. Rizkala, Martin P. Lefkowitz, Victor C. Shi, Jianjian Gong, Nagesh Anavekar, Stefan D. Anker, Juan L. Arango, Jose L. Arenas, Dan Atar, Turia Ben-Gal, Sergey A. Boytsov, Chen Huan Chen, Vijay K. Chopra, John Cleland, Josep Comin-Colet, Hans Dirk Duengen, Luis E. Echeverría Correa, Gerasimos Filippatos, Andreas J. FlammerMichel Galinier, Armando Godoy, Eva Goncalvesova, Stefan Janssens, Tzvetana Katova, Lars Køber, Małgorzata Lelonek, Gerard Linssen, Lars H. Lund, Eileen O'Meara, Béla Merkely, Davor Milicic, Byung Hee Oh, Sergio V. Perrone, Naresh Ranjith, Yoshihiko Saito, Jose F. Saraiva, Sanjiv Shah, Petar M. Seferovic, Michele Senni, Antonio S. Sibulo, David Sim, Nancy K. Sweitzer, Jyrki Taurio, Dragos Vinereanu, Bojan Vrtovec, Jiří Widimský, Mehmet B. Yilmaz, Jingmin Zhou, Robert Zweiker, Inder S. Anand, Junbo Ge, Carolyn S.P. Lam, Aldo P. Maggioni, Felipe Martinez, Milton Packer, Marc A. Pfeffer, Burkert Pieske, Margaret M. Redfield, Jean L. Rouleau, Dirk J. Van Veldhuisen, Faiez Zannad, Michael R. Zile, John J.V. McMurray

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

63 Scopus citations

Abstract

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%), β-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. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

Original language	English (US)
Article number	e004962
Journal	Circulation: Heart Failure
Volume	11
Issue number	7
DOIs	https://doi.org/10.1161/CIRCHEARTFAILURE.118.004962
State	Published - Jul 1 2018

Keywords

angiotensin receptor antagonists
clinical trial
endopeptidases
heart failure, diastolic

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1161/CIRCHEARTFAILURE.118.004962

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Solomon, S. D., Rizkala, A. R., Lefkowitz, M. P., Shi, V. C., Gong, J., Anavekar, N., Anker, S. D., Arango, J. L., Arenas, J. L., Atar, D., Ben-Gal, T., Boytsov, S. A., Chen, C. H., Chopra, V. K., Cleland, J., Comin-Colet, J., Duengen, H. D., Echeverría Correa, L. E., Filippatos, G., ... McMurray, J. J. V. (2018). Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial. Circulation: Heart Failure, 11(7), Article e004962. https://doi.org/10.1161/CIRCHEARTFAILURE.118.004962

Solomon, SD, Rizkala, AR, Lefkowitz, MP, Shi, VC, Gong, J, Anavekar, N, Anker, SD, Arango, JL, Arenas, JL, Atar, D, Ben-Gal, T, Boytsov, SA, Chen, CH, Chopra, VK, Cleland, J, Comin-Colet, J, Duengen, HD, Echeverría Correa, LE, Filippatos, G, Flammer, AJ, Galinier, M, Godoy, A, Goncalvesova, E, Janssens, S, Katova, T, Køber, L, Lelonek, M, Linssen, G, Lund, LH, O'Meara, E, Merkely, B, Milicic, D, Oh, BH, Perrone, SV, Ranjith, N, Saito, Y, Saraiva, JF, Shah, S, Seferovic, PM, Senni, M, Sibulo, AS, Sim, D, Sweitzer, NK, Taurio, J, Vinereanu, D, Vrtovec, B, Widimský, J, Yilmaz, MB, Zhou, J, Zweiker, R, Anand, IS, Ge, J, Lam, CSP, Maggioni, AP, Martinez, F, Packer, M, Pfeffer, MA, Pieske, B, Redfield, MM, Rouleau, JL, Van Veldhuisen, DJ, Zannad, F, Zile, MR & McMurray, JJV 2018, 'Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial', Circulation: Heart Failure, vol. 11, no. 7, e004962. https://doi.org/10.1161/CIRCHEARTFAILURE.118.004962

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title = "Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial",

abstract = "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%), β-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. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.",

keywords = "angiotensin receptor antagonists, clinical trial, endopeptidases, heart failure, diastolic",

author = "Solomon, {Scott D.} and Rizkala, {Adel R.} and Lefkowitz, {Martin P.} and Shi, {Victor C.} and Jianjian Gong and Nagesh Anavekar and Anker, {Stefan D.} and Arango, {Juan L.} and Arenas, {Jose L.} and Dan Atar and Turia Ben-Gal and Boytsov, {Sergey A.} and Chen, {Chen Huan} and Chopra, {Vijay K.} and John Cleland and Josep Comin-Colet and Duengen, {Hans Dirk} and {Echeverr{\'i}a Correa}, {Luis E.} and Gerasimos Filippatos and Flammer, {Andreas J.} and Michel Galinier and Armando Godoy and Eva Goncalvesova and Stefan Janssens and Tzvetana Katova and Lars K{\o}ber and Ma{\l}gorzata Lelonek and Gerard Linssen and Lund, {Lars H.} and Eileen O'Meara and B{\'e}la Merkely and Davor Milicic and Oh, {Byung Hee} and Perrone, {Sergio V.} and Naresh Ranjith and Yoshihiko Saito and Saraiva, {Jose F.} and Sanjiv Shah and Seferovic, {Petar M.} and Michele Senni and Sibulo, {Antonio S.} and David Sim and Sweitzer, {Nancy K.} and Jyrki Taurio and Dragos Vinereanu and Bojan Vrtovec and Ji{\v r}{\'i} Widimsk{\'y} and Yilmaz, {Mehmet B.} and Jingmin Zhou and Robert Zweiker and Anand, {Inder S.} and Junbo Ge and Lam, {Carolyn S.P.} and Maggioni, {Aldo P.} and Felipe Martinez and Milton Packer and Pfeffer, {Marc A.} and Burkert Pieske and Redfield, {Margaret M.} and Rouleau, {Jean L.} and {Van Veldhuisen}, {Dirk J.} and Faiez Zannad and Zile, {Michael R.} and McMurray, {John J.V.}",

note = "Publisher Copyright: {\textcopyright} 2018 American Heart Association, Inc.",

year = "2018",

month = jul,

day = "1",

doi = "10.1161/CIRCHEARTFAILURE.118.004962",

language = "English (US)",

volume = "11",

journal = "Circulation: Heart Failure",

issn = "1941-3289",

publisher = "Lippincott Williams and Wilkins",

number = "7",

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TY - JOUR

T1 - Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial

AU - Solomon, Scott D.

AU - Rizkala, Adel R.

AU - Lefkowitz, Martin P.

AU - Shi, Victor C.

AU - Gong, Jianjian

AU - Anavekar, Nagesh

AU - Anker, Stefan D.

AU - Arango, Juan L.

AU - Arenas, Jose L.

AU - Atar, Dan

AU - Ben-Gal, Turia

AU - Boytsov, Sergey A.

AU - Chen, Chen Huan

AU - Chopra, Vijay K.

AU - Cleland, John

AU - Comin-Colet, Josep

AU - Duengen, Hans Dirk

AU - Echeverría Correa, Luis E.

AU - Filippatos, Gerasimos

AU - Flammer, Andreas J.

AU - Galinier, Michel

AU - Godoy, Armando

AU - Goncalvesova, Eva

AU - Janssens, Stefan

AU - Katova, Tzvetana

AU - Køber, Lars

AU - Lelonek, Małgorzata

AU - Linssen, Gerard

AU - Lund, Lars H.

AU - O'Meara, Eileen

AU - Merkely, Béla

AU - Milicic, Davor

AU - Oh, Byung Hee

AU - Perrone, Sergio V.

AU - Ranjith, Naresh

AU - Saito, Yoshihiko

AU - Saraiva, Jose F.

AU - Shah, Sanjiv

AU - Seferovic, Petar M.

AU - Senni, Michele

AU - Sibulo, Antonio S.

AU - Sim, David

AU - Sweitzer, Nancy K.

AU - Taurio, Jyrki

AU - Vinereanu, Dragos

AU - Vrtovec, Bojan

AU - Widimský, Jiří

AU - Yilmaz, Mehmet B.

AU - Zhou, Jingmin

AU - Zweiker, Robert

AU - Anand, Inder S.

AU - Ge, Junbo

AU - Lam, Carolyn S.P.

AU - Maggioni, Aldo P.

AU - Martinez, Felipe

AU - Packer, Milton

AU - Pfeffer, Marc A.

AU - Pieske, Burkert

AU - Redfield, Margaret M.

AU - Rouleau, Jean L.

AU - Van Veldhuisen, Dirk J.

AU - Zannad, Faiez

AU - Zile, Michael R.

AU - McMurray, John J.V.

PY - 2018/7/1

Y1 - 2018/7/1

N2 - 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%), β-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. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

AB - 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%), β-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. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

KW - angiotensin receptor antagonists

KW - clinical trial

KW - endopeptidases

KW - heart failure, diastolic

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M3 - Article

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AN - SCOPUS:85056774762

SN - 1941-3289

VL - 11

JO - Circulation: Heart Failure

JF - Circulation: Heart Failure

IS - 7

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ER -

Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial

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