TY - JOUR
T1 - Rationale and Design of Low-dose Administration of Carperitide for Acute Heart Failure (LASCAR-AHF)
AU - Nagai, Toshiyuki
AU - Honda, Yasuyuki
AU - Nakano, Hiroki
AU - Honda, Satoshi
AU - Iwakami, Naotsugu
AU - Mizuno, Atsushi
AU - Komiyama, Nobuyuki
AU - Yamane, Takafumi
AU - Furukawa, Yutaka
AU - Miyagi, Tadayoshi
AU - Nishihara, Syuzo
AU - Tanaka, Nobuhiro
AU - Adachi, Taichi
AU - Hamasaki, Toshimitsu
AU - Asaumi, Yasuhide
AU - Tahara, Yoshio
AU - Aiba, Takeshi
AU - Sugano, Yasuo
AU - Kanzaki, Hideaki
AU - Noguchi, Teruo
AU - Kusano, Kengo
AU - Yasuda, Satoshi
AU - Ogawa, Hisao
AU - Anzai, Toshihisa
N1 - Funding Information:
Authors’ Contributions T Nagai and T Anzai conceived of the study and wrote the manuscript and are the grant holders. YH, HN, SH, NI, AM, NK, TY, YF, TM, SN, NT, T Adachi, YA, YT, T Aiba, YS, and HK conceived of and coordinated the study. TH provided the statistical inputs to the study design and protocol. T Noguchi, KK, SY, and HO conceived of and supervised the study. All authors read and approved the final manuscript.FundingThe LASCAR-AHF study was supported by grants from the Japan Research Foundation for Clinical Pharmacology (T Nagai) and the Japan Cardiovascular Research Foundation (29-4-3, T Anzai).
Funding Information:
Conflict of Interest T Nagai received a research grant for studying abroad from the Daiichi Sankyo Foundation of Life Science. T Aiba received a research grant from the Daiichi Sankyo Co, Ltd.
Publisher Copyright:
© 2017, Springer Science+Business Media, LLC.
PY - 2017/12/1
Y1 - 2017/12/1
N2 - Backgrounds: Despite current therapies, acute heart failure (AHF) remains a major public health burden with high rates of in-hospital and post-discharge morbidity and mortality. Carperitide is a recombinantly produced intravenous formulation of human atrial natriuretic peptide that promotes vasodilation with increased salt and water excretion, which leads to reduction of cardiac filling pressures. A previous open-label randomized controlled study showed that carperitide improved long-term cardiovascular mortality and heart failure (HF) hospitalization for patients with AHF, when adding to standard therapy. However, the study was underpowered to detect a difference in mortality because of the small sample size. Methods: Low-dose Administration of Carperitide for Acute Heart Failure (LASCAR-AHF) is a multicenter, randomized, open-label, controlled study designed to evaluate the efficacy of intravenous carperitide in hospitalized patients with AHF. Patients hospitalized for AHF will be randomly assigned to receive either intravenous carperitide (0.02 μg/kg/min) in addition to standard treatment or matching standard treatment for 72 h. The primary end point is death or rehospitalization for HF within 2 years. A total of 260 patients will be enrolled between 2013 and 2018. Conclusion: The design of LASCAR-AHF will provide data of whether carperitide reduces the risk of mortality and rehospitalization for HF in selected patients with AHF.
AB - Backgrounds: Despite current therapies, acute heart failure (AHF) remains a major public health burden with high rates of in-hospital and post-discharge morbidity and mortality. Carperitide is a recombinantly produced intravenous formulation of human atrial natriuretic peptide that promotes vasodilation with increased salt and water excretion, which leads to reduction of cardiac filling pressures. A previous open-label randomized controlled study showed that carperitide improved long-term cardiovascular mortality and heart failure (HF) hospitalization for patients with AHF, when adding to standard therapy. However, the study was underpowered to detect a difference in mortality because of the small sample size. Methods: Low-dose Administration of Carperitide for Acute Heart Failure (LASCAR-AHF) is a multicenter, randomized, open-label, controlled study designed to evaluate the efficacy of intravenous carperitide in hospitalized patients with AHF. Patients hospitalized for AHF will be randomly assigned to receive either intravenous carperitide (0.02 μg/kg/min) in addition to standard treatment or matching standard treatment for 72 h. The primary end point is death or rehospitalization for HF within 2 years. A total of 260 patients will be enrolled between 2013 and 2018. Conclusion: The design of LASCAR-AHF will provide data of whether carperitide reduces the risk of mortality and rehospitalization for HF in selected patients with AHF.
KW - Acute heart failure
KW - Carperitide
KW - Death
KW - Rehospitalization
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U2 - 10.1007/s10557-017-6760-z
DO - 10.1007/s10557-017-6760-z
M3 - Article
C2 - 29098501
AN - SCOPUS:85032892918
SN - 0920-3206
VL - 31
SP - 551
EP - 557
JO - Cardiovascular Drugs and Therapy
JF - Cardiovascular Drugs and Therapy
IS - 5-6
ER -