Application of the H2FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial

Peder L. Myhre; Muthiah Vaduganathan; Brian L. Claggett; Carolyn S.P. Lam; Akshay S. Desai; Inder S. Anand; Nancy K. Sweitzer; James C. Fang; Eileen O'Meara; Sanjiv J. Shah; Amil M. Shah; Eldrin F. Lewis; Jean Rouleau; Bertram Pitt; Scott D. Solomon

doi:10.1002/ejhf.1542

Application of the H₂FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial

Peder L. Myhre, Muthiah Vaduganathan, Brian L. Claggett, Carolyn S.P. Lam, Akshay S. Desai, Inder S. Anand, Nancy K. Sweitzer, James C. Fang, Eileen O'Meara, Sanjiv J. Shah, Amil M. Shah, Eldrin F. Lewis, Jean Rouleau, Bertram Pitt, Scott D. Solomon^*

^*Corresponding author for this work

Medicine, Cardiology Division

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

18 Scopus citations

Original language	English (US)
Pages (from-to)	1288-1291
Number of pages	4
Journal	European Journal of Heart Failure
Volume	21
Issue number	10
DOIs	https://doi.org/10.1002/ejhf.1542
State	Published - Oct 1 2019

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1002/ejhf.1542

Cite this

Myhre, P. L., Vaduganathan, M., Claggett, B. L., Lam, C. S. P., Desai, A. S., Anand, I. S., Sweitzer, N. K., Fang, J. C., O'Meara, E., Shah, S. J., Shah, A. M., Lewis, E. F., Rouleau, J., Pitt, B., & Solomon, S. D. (2019). Application of the H₂FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial. European Journal of Heart Failure, 21(10), 1288-1291. https://doi.org/10.1002/ejhf.1542

@article{a813ba61ba5040bca5cf3b7411cab8de,

title = "Application of the H2FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial",

author = "Myhre, {Peder L.} and Muthiah Vaduganathan and Claggett, {Brian L.} and Lam, {Carolyn S.P.} and Desai, {Akshay S.} and Anand, {Inder S.} and Sweitzer, {Nancy K.} and Fang, {James C.} and Eileen O'Meara and Shah, {Sanjiv J.} and Shah, {Amil M.} and Lewis, {Eldrin F.} and Jean Rouleau and Bertram Pitt and Solomon, {Scott D.}",

note = "Funding Information: Conflict of interest: P.L.M. has received consulting fees from Novartis and is supported by a postdoctoral research grant from the South-Eastern Norway Regional Health Authority, the Norwegian Medical Association and the Unger Vetlesen Medical Fund. M.V. is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for Amgen, AstraZeneca, Bayer AG, and Baxter Healthcare. C.S.P.L. is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma; and has served on the Advisory Board/Steering Committee/Executive Committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck, Janssen Research & Development LLC, Menarini, Boehringer Ingelheim, Novo Nordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, and Darma. A.S.D. has received research grant support from Novartis and consulting fees from Novartis, AstraZeneca, Abbott, Relypsa, and DalCor Pharma. N.K.S. has received research funding from the NIH and Merck. E.O{\textquoteright}M. has received subventions/research support and consulting fees from Novartis, Bayer, AstraZeneca, Servier, and Amgen. S.J.S. has received research grants from Actelion, AstraZeneca, Corvia, and Novartis; and consulting fees from Actelion, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Cardiora, Eisai, Ironwood, Merck, Novartis, Sanofi, and United Therapeutics. A.M.S. has received research support from Novartis and consulting fees from Philips Ultrasound and Bellerophon. The work for this manuscript was also supported by NIH/NHLBI grants K08HL116792, R01HL135008, and R01HL143224. E.F.L. has received research grants from NHLBI, Novartis, and Sanofi; and consults for Novar-tis. B.P. reports receiving consulting fees from Amorcyte, AstraZeneca, Aurasense, Bayer, BG Medicine, Gambro, Johnson & Johnson, Mesoblast, Novartis, Pfizer, Relypsa, and Takeda; receiving research grant support from Forest Laboratories; and holding stock in Aurasense, Relypsa, BG Medicine, and Aurasense. He also reports a pending patent related to site specific delivery of eplerenone to the myocardium. S.D.S. has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Celladon, Gilead, GSK, Ionis Pharmaceutics, Lone Star Funding Information: TOPCAT was supported by the NHLBI (HHSN268200425207C). Conflict of interest: P.L.M. has received consulting fees from Novartis and is supported by a postdoctoral research grant from the South-Eastern Norway Regional Health Authority, the Norwegian Medical Association and the Unger Vetlesen Medical Fund. M.V. is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for Amgen, AstraZeneca, Bayer AG, and Baxter Healthcare. C.S.P.L. is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma; and has served on the Advisory Board/Steering Committee/Executive Committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck, Janssen Research & Development LLC, Menarini, Boehringer Ingelheim, Novo Nordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, and Darma. A.S.D. has received research grant support from Novartis and consulting fees from Novartis, AstraZeneca, Abbott, Relypsa, and DalCor Pharma. N.K.S. has received research funding from the NIH and Merck. E.O'M. has received subventions/research support and consulting fees from Novartis, Bayer, AstraZeneca, Servier, and Amgen. S.J.S. has received research grants from Actelion, AstraZeneca, Corvia, and Novartis; and consulting fees from Actelion, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Cardiora, Eisai, Ironwood, Merck, Novartis, Sanofi, and United Therapeutics. A.M.S. has received research support from Novartis and consulting fees from Philips Ultrasound and Bellerophon. The work for this manuscript was also supported by NIH/NHLBI grants K08HL116792, R01HL135008, and R01HL143224. E.F.L. has received research grants from NHLBI, Novartis, and Sanofi; and consults for Novartis. B.P. reports receiving consulting fees from Amorcyte, AstraZeneca, Aurasense, Bayer, BG Medicine, Gambro, Johnson & Johnson, Mesoblast, Novartis, Pfizer, Relypsa, and Takeda; receiving research grant support from Forest Laboratories; and holding stock in Aurasense, Relypsa, BG Medicine, and Aurasense. He also reports a pending patent related to site specific delivery of eplerenone to the myocardium. S.D.S. has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Celladon, Gilead, GSK, Ionis Pharmaceutics, Lone Star Heart, Mesoblast, MyoKardia, NIH/NHLBI, Novartis, Sanofi Pasteur, Theracos, and has consulted for Alnylam, Amgen, AstraZeneca, Bayer, BMS, Corvia, Gilead, GSK, Ironwood, Merck, Novartis, Pfizer, Takeda, and Theracos. All other authors report no other relationships relevant to the contents of this paper to disclose. We would like to acknowledge the contributions of the TOPCAT participants, site investigators, and leadership, including the clinical events committee (Brigham and Women's Hospital, Boston, MA, USA). TOPCAT was supported by the NHLBI (HHSN268200425207C). Conflict of interest: P.L.M. has received consulting fees from Novartis and is supported by a postdoctoral research grant from the South-Eastern Norway Regional Health Authority, the Norwegian Medical Association and the Unger Vetlesen Medical Fund. M.V. is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for Amgen, AstraZeneca, Bayer AG, and Baxter Healthcare. C.S.P.L. is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma; and has served on the Advisory Board/Steering Committee/Executive Committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck, Janssen Research & Development LLC, Menarini, Boehringer Ingelheim, Novo Nordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, and Darma. A.S.D. has received research grant support from Novartis and consulting fees from Novartis, AstraZeneca, Abbott, Relypsa, and DalCor Pharma. N.K.S. has received research funding from the NIH and Merck. E.O'M. has received subventions/research support and consulting fees from Novartis, Bayer, AstraZeneca, Servier, and Amgen. S.J.S. has received research grants from Actelion, AstraZeneca, Corvia, and Novartis; and consulting fees from Actelion, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Cardiora, Eisai, Ironwood, Merck, Novartis, Sanofi, and United Therapeutics. A.M.S. has received research support from Novartis and consulting fees from Philips Ultrasound and Bellerophon. The work for this manuscript was also supported by NIH/NHLBI grants K08HL116792, R01HL135008, and R01HL143224. E.F.L. has received research grants from NHLBI, Novartis, and Sanofi; and consults for Novartis. B.P. reports receiving consulting fees from Amorcyte, AstraZeneca, Aurasense, Bayer, BG Medicine, Gambro, Johnson & Johnson, Mesoblast, Novartis, Pfizer, Relypsa, and Takeda; receiving research grant support from Forest Laboratories; and holding stock in Aurasense, Relypsa, BG Medicine, and Aurasense. He also reports a pending patent related to site specific delivery of eplerenone to the myocardium. S.D.S. has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Celladon, Gilead, GSK, Ionis Pharmaceutics, Lone Star Heart, Mesoblast, MyoKardia, NIH/NHLBI, Novartis, Sanofi Pasteur, Theracos, and has consulted for Alnylam, Amgen, AstraZeneca, Bayer, BMS, Corvia, Gilead, GSK, Ironwood, Merck, Novartis, Pfizer, Takeda, and Theracos. All other authors report no other relationships relevant to the contents of this paper to disclose.",

year = "2019",

month = oct,

day = "1",

doi = "10.1002/ejhf.1542",

language = "English (US)",

volume = "21",

pages = "1288--1291",

journal = "European Journal of Heart Failure",

issn = "1388-9842",

publisher = "Oxford University Press",

number = "10",

}

Myhre, PL, Vaduganathan, M, Claggett, BL, Lam, CSP, Desai, AS, Anand, IS, Sweitzer, NK, Fang, JC, O'Meara, E, Shah, SJ, Shah, AM, Lewis, EF, Rouleau, J, Pitt, B & Solomon, SD 2019, 'Application of the H₂FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial', European Journal of Heart Failure, vol. 21, no. 10, pp. 1288-1291. https://doi.org/10.1002/ejhf.1542

TY - JOUR

T1 - Application of the H2FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction

T2 - the TOPCAT trial

AU - Myhre, Peder L.

AU - Vaduganathan, Muthiah

AU - Claggett, Brian L.

AU - Lam, Carolyn S.P.

AU - Desai, Akshay S.

AU - Anand, Inder S.

AU - Sweitzer, Nancy K.

AU - Fang, James C.

AU - O'Meara, Eileen

AU - Shah, Sanjiv J.

AU - Shah, Amil M.

AU - Lewis, Eldrin F.

AU - Rouleau, Jean

AU - Pitt, Bertram

AU - Solomon, Scott D.

N1 - Funding Information: Conflict of interest: P.L.M. has received consulting fees from Novartis and is supported by a postdoctoral research grant from the South-Eastern Norway Regional Health Authority, the Norwegian Medical Association and the Unger Vetlesen Medical Fund. M.V. is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for Amgen, AstraZeneca, Bayer AG, and Baxter Healthcare. C.S.P.L. is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma; and has served on the Advisory Board/Steering Committee/Executive Committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck, Janssen Research & Development LLC, Menarini, Boehringer Ingelheim, Novo Nordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, and Darma. A.S.D. has received research grant support from Novartis and consulting fees from Novartis, AstraZeneca, Abbott, Relypsa, and DalCor Pharma. N.K.S. has received research funding from the NIH and Merck. E.O’M. has received subventions/research support and consulting fees from Novartis, Bayer, AstraZeneca, Servier, and Amgen. S.J.S. has received research grants from Actelion, AstraZeneca, Corvia, and Novartis; and consulting fees from Actelion, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Cardiora, Eisai, Ironwood, Merck, Novartis, Sanofi, and United Therapeutics. A.M.S. has received research support from Novartis and consulting fees from Philips Ultrasound and Bellerophon. The work for this manuscript was also supported by NIH/NHLBI grants K08HL116792, R01HL135008, and R01HL143224. E.F.L. has received research grants from NHLBI, Novartis, and Sanofi; and consults for Novar-tis. B.P. reports receiving consulting fees from Amorcyte, AstraZeneca, Aurasense, Bayer, BG Medicine, Gambro, Johnson & Johnson, Mesoblast, Novartis, Pfizer, Relypsa, and Takeda; receiving research grant support from Forest Laboratories; and holding stock in Aurasense, Relypsa, BG Medicine, and Aurasense. He also reports a pending patent related to site specific delivery of eplerenone to the myocardium. S.D.S. has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Celladon, Gilead, GSK, Ionis Pharmaceutics, Lone Star Funding Information: TOPCAT was supported by the NHLBI (HHSN268200425207C). Conflict of interest: P.L.M. has received consulting fees from Novartis and is supported by a postdoctoral research grant from the South-Eastern Norway Regional Health Authority, the Norwegian Medical Association and the Unger Vetlesen Medical Fund. M.V. is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for Amgen, AstraZeneca, Bayer AG, and Baxter Healthcare. C.S.P.L. is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma; and has served on the Advisory Board/Steering Committee/Executive Committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck, Janssen Research & Development LLC, Menarini, Boehringer Ingelheim, Novo Nordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, and Darma. A.S.D. has received research grant support from Novartis and consulting fees from Novartis, AstraZeneca, Abbott, Relypsa, and DalCor Pharma. N.K.S. has received research funding from the NIH and Merck. E.O'M. has received subventions/research support and consulting fees from Novartis, Bayer, AstraZeneca, Servier, and Amgen. S.J.S. has received research grants from Actelion, AstraZeneca, Corvia, and Novartis; and consulting fees from Actelion, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Cardiora, Eisai, Ironwood, Merck, Novartis, Sanofi, and United Therapeutics. A.M.S. has received research support from Novartis and consulting fees from Philips Ultrasound and Bellerophon. The work for this manuscript was also supported by NIH/NHLBI grants K08HL116792, R01HL135008, and R01HL143224. E.F.L. has received research grants from NHLBI, Novartis, and Sanofi; and consults for Novartis. B.P. reports receiving consulting fees from Amorcyte, AstraZeneca, Aurasense, Bayer, BG Medicine, Gambro, Johnson & Johnson, Mesoblast, Novartis, Pfizer, Relypsa, and Takeda; receiving research grant support from Forest Laboratories; and holding stock in Aurasense, Relypsa, BG Medicine, and Aurasense. He also reports a pending patent related to site specific delivery of eplerenone to the myocardium. S.D.S. has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Celladon, Gilead, GSK, Ionis Pharmaceutics, Lone Star Heart, Mesoblast, MyoKardia, NIH/NHLBI, Novartis, Sanofi Pasteur, Theracos, and has consulted for Alnylam, Amgen, AstraZeneca, Bayer, BMS, Corvia, Gilead, GSK, Ironwood, Merck, Novartis, Pfizer, Takeda, and Theracos. All other authors report no other relationships relevant to the contents of this paper to disclose. We would like to acknowledge the contributions of the TOPCAT participants, site investigators, and leadership, including the clinical events committee (Brigham and Women's Hospital, Boston, MA, USA). TOPCAT was supported by the NHLBI (HHSN268200425207C). Conflict of interest: P.L.M. has received consulting fees from Novartis and is supported by a postdoctoral research grant from the South-Eastern Norway Regional Health Authority, the Norwegian Medical Association and the Unger Vetlesen Medical Fund. M.V. is supported by the KL2/Catalyst Medical Research Investigator Training award from Harvard Catalyst (NIH/NCATS Award UL 1TR002541), and serves on advisory boards for Amgen, AstraZeneca, Bayer AG, and Baxter Healthcare. C.S.P.L. is supported by a Clinician Scientist Award from the National Medical Research Council of Singapore; has received research support from Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, and Vifor Pharma; and has served on the Advisory Board/Steering Committee/Executive Committee for Boston Scientific, Bayer, Roche Diagnostics, AstraZeneca, Medtronic, Vifor Pharma, Novartis, Amgen, Merck, Janssen Research & Development LLC, Menarini, Boehringer Ingelheim, Novo Nordisk, Abbott Diagnostics, Corvia, Stealth BioTherapeutics, JanaCare, Biofourmis, and Darma. A.S.D. has received research grant support from Novartis and consulting fees from Novartis, AstraZeneca, Abbott, Relypsa, and DalCor Pharma. N.K.S. has received research funding from the NIH and Merck. E.O'M. has received subventions/research support and consulting fees from Novartis, Bayer, AstraZeneca, Servier, and Amgen. S.J.S. has received research grants from Actelion, AstraZeneca, Corvia, and Novartis; and consulting fees from Actelion, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, Cardiora, Eisai, Ironwood, Merck, Novartis, Sanofi, and United Therapeutics. A.M.S. has received research support from Novartis and consulting fees from Philips Ultrasound and Bellerophon. The work for this manuscript was also supported by NIH/NHLBI grants K08HL116792, R01HL135008, and R01HL143224. E.F.L. has received research grants from NHLBI, Novartis, and Sanofi; and consults for Novartis. B.P. reports receiving consulting fees from Amorcyte, AstraZeneca, Aurasense, Bayer, BG Medicine, Gambro, Johnson & Johnson, Mesoblast, Novartis, Pfizer, Relypsa, and Takeda; receiving research grant support from Forest Laboratories; and holding stock in Aurasense, Relypsa, BG Medicine, and Aurasense. He also reports a pending patent related to site specific delivery of eplerenone to the myocardium. S.D.S. has received research grants from Alnylam, Amgen, AstraZeneca, Bellerophon, Celladon, Gilead, GSK, Ionis Pharmaceutics, Lone Star Heart, Mesoblast, MyoKardia, NIH/NHLBI, Novartis, Sanofi Pasteur, Theracos, and has consulted for Alnylam, Amgen, AstraZeneca, Bayer, BMS, Corvia, Gilead, GSK, Ironwood, Merck, Novartis, Pfizer, Takeda, and Theracos. All other authors report no other relationships relevant to the contents of this paper to disclose.

PY - 2019/10/1

Y1 - 2019/10/1

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UR - http://www.scopus.com/inward/citedby.url?scp=85074244049&partnerID=8YFLogxK

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DO - 10.1002/ejhf.1542

M3 - Letter

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AN - SCOPUS:85074244049

SN - 1388-9842

VL - 21

SP - 1288

EP - 1291

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

IS - 10

ER -

Application of the H2FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial

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Application of the H₂FPEF score to a global clinical trial of patients with heart failure with preserved ejection fraction: the TOPCAT trial