Abstract
Introduction Type 2 diabetes mellitus (T2DM) is a strong risk factor for coronary artery disease and heart failure, particularly heart failure with preserved ejection fraction (HFpEF). The aim of the ongoing MUSCAT-HF (It stands for Prospective Comparison of Luseogliflozin and Alpha-glucosidase on the Management of Diabetic Patients with Chronic Heart Failure and Preserved Ejection Fraction) trial is to evaluate the efficacy of luseogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, versus voglibose, an alpha-glucosidase inhibitor, using brain natriuretic peptide (BNP) as the index of therapeutic effect in T2DM patients with HFpEF. Methods and analysis A total of 190 patients with T2DM and HFpEF (ejection fraction >45%) who are drug-naïve or taking any anti-diabetic agents will be randomised (1:1) to receive luseogliflozin 2.5 mg one time per day or voglibose 0.2 mg three times per day. The patients will be stratified by age (<65 years, ≥65 years), baseline haemoglobin A1c (<8.0%, ≥8.0%), baseline BNP (<100 pg/mL, ≥100 pg/mL), baseline renal function (estimated glomerular filtration rate ≥60 mL/min/1.73 m 2, <60 mL/min/1.73 m 2), use of thiazolidine or not and presence or absence of atrial fibrillation and flutter at screening. After randomisation, participants will receive the study drug for 12 weeks in addition to their background therapy. The primary endpoint is the proportional change in baseline BNP after 12 weeks of treatment. The key secondary endpoints are the change from baseline in the ratio of early mitral inflow velocity to mitral annular early diastolic velocity, body weight and glycaemic control after 12 weeks of treatment. Ethics and dissemination The study has been approved by the ethics committee and the patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals. Trial registration number UMIN000018395.
| Original language | English |
|---|---|
| Article number | e026590 |
| Journal | BMJ Open |
| Volume | 9 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 1 2019 |
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Keywords
- brain natriuretic peptide
- heart failure
- luseogliflozin
- sodium-glucose cotransporter 2 inhibitor
- type 2 diabetes mellitus
- voglibose
ASJC Scopus subject areas
- Medicine(all)
Cite this
The effect of luseogliflozin and alpha-glucosidase inhibitor on heart failure with preserved ejection fraction in diabetic patients : Rationale and design of the MUSCAT-HF randomised controlled trial. / Ejiri, Kentaro; Miyoshi, Toru; Nakamura, Kazufumi; Sakuragi, Satoru; Munemasa, Mitsuru; Namba, Seiji; Takaishi, Atsushi; Itoh, Hiroshi.
In: BMJ Open, Vol. 9, No. 3, e026590, 01.03.2019.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The effect of luseogliflozin and alpha-glucosidase inhibitor on heart failure with preserved ejection fraction in diabetic patients
T2 - Rationale and design of the MUSCAT-HF randomised controlled trial
AU - Ejiri, Kentaro
AU - Miyoshi, Toru
AU - Nakamura, Kazufumi
AU - Sakuragi, Satoru
AU - Munemasa, Mitsuru
AU - Namba, Seiji
AU - Takaishi, Atsushi
AU - Itoh, Hiroshi
PY - 2019/3/1
Y1 - 2019/3/1
N2 - Introduction Type 2 diabetes mellitus (T2DM) is a strong risk factor for coronary artery disease and heart failure, particularly heart failure with preserved ejection fraction (HFpEF). The aim of the ongoing MUSCAT-HF (It stands for Prospective Comparison of Luseogliflozin and Alpha-glucosidase on the Management of Diabetic Patients with Chronic Heart Failure and Preserved Ejection Fraction) trial is to evaluate the efficacy of luseogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, versus voglibose, an alpha-glucosidase inhibitor, using brain natriuretic peptide (BNP) as the index of therapeutic effect in T2DM patients with HFpEF. Methods and analysis A total of 190 patients with T2DM and HFpEF (ejection fraction >45%) who are drug-naïve or taking any anti-diabetic agents will be randomised (1:1) to receive luseogliflozin 2.5 mg one time per day or voglibose 0.2 mg three times per day. The patients will be stratified by age (<65 years, ≥65 years), baseline haemoglobin A1c (<8.0%, ≥8.0%), baseline BNP (<100 pg/mL, ≥100 pg/mL), baseline renal function (estimated glomerular filtration rate ≥60 mL/min/1.73 m 2, <60 mL/min/1.73 m 2), use of thiazolidine or not and presence or absence of atrial fibrillation and flutter at screening. After randomisation, participants will receive the study drug for 12 weeks in addition to their background therapy. The primary endpoint is the proportional change in baseline BNP after 12 weeks of treatment. The key secondary endpoints are the change from baseline in the ratio of early mitral inflow velocity to mitral annular early diastolic velocity, body weight and glycaemic control after 12 weeks of treatment. Ethics and dissemination The study has been approved by the ethics committee and the patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals. Trial registration number UMIN000018395.
AB - Introduction Type 2 diabetes mellitus (T2DM) is a strong risk factor for coronary artery disease and heart failure, particularly heart failure with preserved ejection fraction (HFpEF). The aim of the ongoing MUSCAT-HF (It stands for Prospective Comparison of Luseogliflozin and Alpha-glucosidase on the Management of Diabetic Patients with Chronic Heart Failure and Preserved Ejection Fraction) trial is to evaluate the efficacy of luseogliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, versus voglibose, an alpha-glucosidase inhibitor, using brain natriuretic peptide (BNP) as the index of therapeutic effect in T2DM patients with HFpEF. Methods and analysis A total of 190 patients with T2DM and HFpEF (ejection fraction >45%) who are drug-naïve or taking any anti-diabetic agents will be randomised (1:1) to receive luseogliflozin 2.5 mg one time per day or voglibose 0.2 mg three times per day. The patients will be stratified by age (<65 years, ≥65 years), baseline haemoglobin A1c (<8.0%, ≥8.0%), baseline BNP (<100 pg/mL, ≥100 pg/mL), baseline renal function (estimated glomerular filtration rate ≥60 mL/min/1.73 m 2, <60 mL/min/1.73 m 2), use of thiazolidine or not and presence or absence of atrial fibrillation and flutter at screening. After randomisation, participants will receive the study drug for 12 weeks in addition to their background therapy. The primary endpoint is the proportional change in baseline BNP after 12 weeks of treatment. The key secondary endpoints are the change from baseline in the ratio of early mitral inflow velocity to mitral annular early diastolic velocity, body weight and glycaemic control after 12 weeks of treatment. Ethics and dissemination The study has been approved by the ethics committee and the patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals. Trial registration number UMIN000018395.
KW - brain natriuretic peptide
KW - heart failure
KW - luseogliflozin
KW - sodium-glucose cotransporter 2 inhibitor
KW - type 2 diabetes mellitus
KW - voglibose
UR - http://www.scopus.com/inward/record.url?scp=85063677678&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85063677678&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2018-026590
DO - 10.1136/bmjopen-2018-026590
M3 - Article
C2 - 30928954
AN - SCOPUS:85063677678
VL - 9
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 3
M1 - e026590
ER -