M201-A-CT-004 ( )
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 112
- 主要终点
- Assessment of congestion
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 86age old not（—）
- 性别
- All
入选标准
- •Subjects who meet all of the following criteria will be eligible for this clinical trial.
- •(1) Japanese adult, male or female
- •(2) Persons who are hospitalized or currently hospitalized due to worsening of heart failure* despite using oral heart failure medications (including oral diuretics)
- •: Exacerbation of heart failure is a condition in which one or more of the following is observed: dyspnea, pulmonary congestion, pulmonary rales, onset or progression of edema, and short-term weight gain.
- •(3) Persons who are 20 years or older and less than 86 years old on Day -2 before the start of the study drug administration
- •(4) Persons with heart failure determined to be grade II or III according to NYHA classification (HFrEF, HFmrEF, or HFpEF)
- •(5) Persons with eGFR less than 60 mL/min/1.73 m2 and more than 30 mL/min/1.73 m2
- •(6) Those whose weight is 40 kg or more for women and 45 kg or more for men, and whose BMI* is 18.0 or more and less than 30.
- •: BMI = Weight (kg) / [Height (m)2] (rounded down to the second decimal place)
- •(7) Subjects who are able to measure urine storage and water intake, and measure body weight after urinating every morning before administering the study drug.
- •(8) Subjects who have given written consent to participate in this clinical trial based on their own free will.
排除标准
- •In this clinical trial, subjects who fall under any of the following exclusion criteria will not be included in this clinical trial, considering the impact on subject safety and efficacy.
- •(1) Persons hospitalized for acute myocardial infarction and less than 30 days after onset of symptoms
- •(2) Persons with cardiogenic shock
- •(3) Subjects who received emergency infusion treatment with catecholamines, carperitide (hANP), tolvaptan sodium phosphate (Samutas), or vasodilators, which are injectable treatments for heart failure, within 30 days before the start of study drug administration.
- •(4) Loop diuresis must be completed within 32 hours before the scheduled morning administration time on Day 1 (if administration starts at 9 a.m. on Day 1, from 1 a.m. on Day -1 until before the start of study drug administration on Day 1). Those who received a bolus dose of drug injections
- •If a bolus of the above loop diuretic injection is administered on Day -1, Day -1 shall be reset and the necessary tests shall be conducted. For handling when using loop diuretic injections, see "7.9 Emergency Measures/Treatment."
- •(5) Subjects who used antiarrhythmic drugs for the period specified below before starting study drug administration.
- •Amiodarone: within 1 year
- •Group IV (bepridil): within 14 days
- •Group Ia, Group Ic, Group III: within 7 days
- •For details on drugs applicable to Group Ia, Group Ic, and Group III, see Table 7.8-1 in "7.8.1 Drugs prohibited for concomitant use."
- •(6) Those whose creatinine value exceeds 2.5 mg/dL
- •(7) Subjects who have newly administered, changed the dose, or discontinued an SGLT2 inhibitor within 120 days before starting study drug administration.
- •(8) Subjects with QTcF of 440 ms or more in standard 12-lead electrocardiogram measurement. However, this standard does not apply to patients with atrial fibrillation.
- •(9) Persons with risk factors for torsade de pointes (TdP) (e.g., hypokalemia, hypomagnesemia, history or complications of unexplained syncope, long QT syndrome or a family history thereof) etc)
- •(10) Persons with BNP less than 100 pg/mL or NT-proBNP less than 400 pg/mL
- •(11) Tests from 6 months before administration of the study drug to Day -1
- •and whose serum potassium level has ever been less than 3.6 mEq/L or more than 5.5 mEq/L
- •Subjects whose serum magnesium level has been found to be 1.8 mg/dL or less at least once during a test between 6 months before administration of the study drug and Day -
- •(13) Persons with blood hemoglobin levels less than 9 g/dL
- •(14) Persons with bradycardia with heart rate below 50 or sinus arrest for 2 seconds or more
- •(15) Persons with grade II Mobitz type atrioventricular block or grade III atrioventricular block
- •(16) Persons with systolic blood pressure less than 90 mmHg
- •(17) Persons with sustained ventricular tachycardia
- •(18) Persons who have a cardiac assist circulation device or a biventricular pacemaker implanted.
- •(19) Those who have undergone cardiac surgery within 60 days before administration of the study drug
- •(20) Persons undergoing endotracheal intubation
- •(21) Persons undergoing artificial dialysis
- •(22) Persons with treatment-resistant, refractory, or end-stage heart failure who are considered for special treatment including ventricular assist device or heart transplantation.
- •(23) Persons with severe aortic valve stenosis, severe left ventricular hypertrophy, serious gastrointestinal (gastrointestinal, liver, gallbladder, bile duct, pancreas, etc.) diseases, severe thyroid dysfunction, or those who are undergoing treatment with serious respiratory disease, blood disease, or anti-cancer drugs.
- •(24) Do not use drugs, herbs, drinks, etc. that may inhibit or induce QT prolongation and cytochrome P450 3A (see Tables 7.8-2 and 7.8-3 in "7.8.1 Drugs prohibited for concomitant use"). person who is
- •(25) Persons with a history of epileptic seizures or organic brain disorders that may induce epileptic seizures.
- •(26) Persons with a history of anaphylaxis
- •(27) Subjects who have received a blood transfusion of 200 mL or more or blood component transfusion within 3 months before administration of the study drug.
- •(28) Those who do not agree to quit smoking during this study period
- •(29) Persons who have tested positive for any of the drug of abuse test items
- •(30) Persons with alcoholism or a history of alcoholism
- •(31) Persons who cannot agree not to consume coffee, oolong tea, green tea, or black tea during hospitalization.
- •(32) Persons who have participated in clinical trials of other drugs, medical devices, regenerative medicine products, etc. within 3 months before administration of the investigational drug.
- •(33) Those who cannot consent to contraception* for 90 days after administration of the study drug
- •: Use medically appropriate methods of contraception (condoms, contraceptive pills, etc.)
- •(34) Pregnant women, lactating women, and those who may be pregnant*
- •: For subjects who may be pregnant, the presence or absence of pregnancy will be confirmed using a pregnancy test (such as one based on the beta-subunit of HCG) at screening, Day -1, and Day 39 post-tests.
- •(35) Persons who have received M201-A hydrochloride in the past
- •(36) Others who are judged by the principal investigator (co-investigator) to be unsuitable subjects for this study.
结局指标
主要结局
Assessment of congestion
Edema, pulmonary crackles
Adverse events and side effects
Safety evaluation items
Vital signs
Body temperature, blood pressure/pulse rate
Laboratory test values
General blood/biochemical tests, blood renal function tests, urinalysis (qualitative/biochemistry), urinalysis (kidney function)
Urine volume
Effectiveness evaluation items
Water balance
Difference between the amount of water consumed, amount of water in meals, amount of transfusion, etc., and urine amount
Renal function indicators
Serum Cre, serum BUN, serum Cystatine C, eGFRcystatine, eGFRcre, CCr, urinary NAG, urinary beta2 microglobulin, urinary L-FABP, urinary albumin, etc.
Inferior vena cava diameter
During inspiration and expiration
Percentage of subjects who were readmitted to the hospital
时间窗: Day 39 after discharge
By Day 39 after discharge
Percentage of subjects who received a bolus of loop diuretic injection
时间窗: Day 1 to Day 8
Between Day 1 and Day 8
Percentage of subjects who died
时间窗: Day 1 to Day 39
From the start of study drug administration (Day 1) to Day 39
Cardiac function measured by cardiac ultrasound
Cardiac chamber inner diameter size, ventricular wall motion, left ventricular shortening (FS), left ventricular ejection fraction (EF), tricuspid regurgitation pressure gradient, left ventricular inflow Fast waveform (early diastolic wave/atrial systolic wave: E/A), E wave deceleration time (DT), left ventricular early diastolic wave/mitral valve annulus movement speed E/E', Presence of pericardial effusion, aortic diameter (AoD), left atrial diameter (LAD), left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs), left ventricular wall thickness [ventricular septal thickness (IVSth)], posterior wall thickness (PWth)], left ventricular outflow tract waveform (LVOF VTI), left atrial volume index (LAVI)
Percentage of subjects who received additional/emergency drug therapy for heart failure
时间窗: Day 1 to Day 8
Between Day 1 and Day 8 and discontinued it
Changes in physical activity before and after administration of study drug
时间窗: Admission, Day 9, Day 16, Day 39
At admission, Day 9, and post-test (Day 16, Day 39) Physical activity questionnaire completed by a physician
Plasma drug concentration
Pharmacokinetic endpoints
Urinary drug concentration
Urinary excretion amount, urinary excretion rate
次要结局
未报告次要终点