jRCTs031210682招募中不适用
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Empagliflozin in Patients with Acute Heart Failure
未提供0 个研究点目标入组 524 人开始时间: 2022年9月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 524
- 主要终点
- Win ratio
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 No limit（—）
- 性别
- All
入选标准
- •Age 20 years and over
- •If the patient is 90 years of age or older and cognitive decline is considered necessary, Mini-Cog should be used to confirm that its score is not less than
- •Patients who have been hospitalized with a diagnosis of acute heart failure and require intravenous loop diuretic therapy, and meet all the following:
- •i) Dyspnea at rest or induced by slight exertion
- •ii) Have at least two of the following findings: jugular venous distention, pulmonary rales, lower leg edema, and pulmonary congestion on a plain film
- •iii) If the patient has a sinus rhythm at the time of admission, brain natriuretic peptide (BNP) >=350 pg/mL or NT-proBNP >=1400 pg/mL; if the patient has atrial fibrillation at the time of admission, BNP >=500 pg/mL or NT-proBNP >=2000 pg/mL.
- •Patients who meet at least one of the following:
- •i) Estimated glomerular filtration rate (eGFR) <60 mL/min/1.72m^2
- •ii) Patients who have been taking loop diuretics >=40 mg of furosemide daily prior to hospitalization
- •iii) Urine output of <300 mL during 2 h following an adequate dose of intravenous furosemide
- •Patients who have given written consent to participate in the study
排除标准
- •eGFR <20 mL/min/1.73m^2 at the time of admission
- •Patients who have taken SGLT2 inhibitors within 3 months prior to admission
- •Type 1 diabetes mellitus
- •Systolic blood pressure < 90 mmHg
- •Are expected to newly require treatment with thiazide, tolvaptan, or carperitide from time of admission to within 48 hours of study drug administration
- •Acute heart failure hospitalization, the main cause of which is not fluid retention (e.g., persistent ventricular tachycardia, persistent atrial fibrillation / atrial flutter with a ventricular response rate of >=130, persistent bradycardia with a ventricular response rate of <45, an infection, severe anemia, and an acute exacerbation of chronic obstructive pulmonary disease - COPD)
- •Acute coronary syndrome, pulmonary thromboembolism, or a cerebrovascular accident is the main cause of the present hospitalization.
- •Have a risk of ketoacidosis or hyperosmolar hyperglycemia
- •Patients who are on dialysis including peritoneal dialysis or in whom the initiation of dialysis during hospitalization is planned
- •Pregnant or lactating women
- •Have undergone the following therapeutic intervention within 30 days: cardiovascular surgery (e.g., coronary artery bypass grafting, surgery for valvular heart disease,
- •transcatheter aortic valve implantation, percutaneous coronary intervention, percutaneous edge to edge mitral valve repair, and other types of surgery at the investigator's discretion) and implantation of an implantable defibrillator, a cardiac resynchronization therapy defibrillator, or an implantable ventricular assist device
- •A diagnosis of acute coronary syndrome, cerebral infarction, or transient ischemic attack made within 90 days
- •Findings of ventricular tachycardia with syncope revealed within 90 days
- •Heart transplant recipients or patients listed for heart transplantation who are expected to undergo transplantation during the present treatment, patients implanted with an implantable ventricular assist device, patients expected to require an implantable ventricular assist device during the present treatment, and patients expected to switch to palliative care
- •Patients intubated at the time of screening or patients expected to require intubation within 48 h after study drug administration
- •Severe valvular heart disease expected to be treated with thoracotomy or catheterization (there is no reason to exclude secondary mitral or tricuspid regurgitation due to reduced cardiac function, except for the absence of a plan to perform cardiac surgery or therapeutic catheterization)
- •Patients with a diagnosis of secondary cardiomyopathy such as amyloidosis, cardiac sarcoidosis, hemochromatosis, Fabry's disease, and muscular dystrophy. Heart failure due to takotsubo cardiomyopathy, obstructive hypertrophic cardiomyopathy, complex congenital heart disease (as determined by the investigator), or pericardial constriction
- •A diagnosis of peripartum cardiomyopathy made within 6 months
- •Active myocarditis
- •Presence of uncontrolled thyroid disease
- •Acute cardiac structural abnormalities (e.g., acute mitral regurgitation due to ruptured chordae tendineae)
- •Patients with symptomatic bradycardia or complete atrioventricular block who are being treated with temporary pacemaker implantation at the time of admission, or who are expected to require temporary pacemaker implantation in the future. Patients who have already been treated with permanent pacemaker implantation do not meet the exclusion criteria
- •Serious liver disorder (an increase in AST, ALT, or ALP >= 3 times the upper limit of normal) or cirrhosis with varices or other findings suggestive of portal hypertension
- •Patients judged to be at least mildly affected by the DSM-V alcohol use disorder diagnostic criteria
- •A diagnosis of active malignancy or suspected active malignancy made within 2 years
- •Coexisting diseases other than heart failure with an expected survival prognosis of <=1 year
- •Participation in a clinical study of another drug 30 days before the hospitalization
- •Patients considered to require fasting management at screening period
- •Other conditions likely to interfere with the patient's safety or compliance with the protocol
- •Patients who are judged to be unsuitable by the principal investigator or the investigator.
结局指标
主要结局
Win ratio
时间窗: 90 days for death and readmission; during hospitalization for re-exacerbation; up to 48 hours for urine output
Hierarchical composite endpoint consisting of: - Death within 90 days of randomization - Heart failure readmission within 90 days of randomization - Heart failure re-exacerbation during hospitalization - Urine output up to 48 hours after starting treatment
次要结局
- Win ratio for a hierarchical composite endpoint(90 days)
- Composite endpoint(90 days)
- Group differences in NT-proBNP(48 hours)
- Diuretic response(48 hours)
- Improvement of KCCQ-TSS(30 and 90 days after randomization)
- Re-exacerbation of heart failure(During hospitalization)
- Heart failure rehospitalization(90 days)
- Death(90 days)
- Urine output(48 hours)
- Cardiovascular death(90 days)
- Change in VAS for dyspnea(24, 48 hours after randomization)
- Between-group difference in high-sensitivity troponin T(48 hours)
- Change in KCCQ-TSS(30 and 90 days after randomization)
- Renal replacement therapy and related endpoints(90 days)
- eGFR(24, 48 hours, 30 days, and 90 days after randomization)
- Readmission
研究者
相似试验
尚未招募
4 期
Efficacy and Safety of empagliflozin in patients with hepatic ascites: a randomized controlled trialDigestive SystemPACTR202402866059449one60
招募中
4 期
The effect of empagliflozin in patients with idiopathic edemaIdiopathic edema.Edema, unspecifiedR60.9IRCT20230314057712N1Ahvaz University of Medical Sciences70
尚未招募
3 期
Assessment of effectiveness of Empagliflozin in the management of Anemia in diabetes patientsCTRI/2024/02/063292SRM Insitute of Science and Technology
招募中
3 期
Evaluation of the effectiveness of Empagliflozin on metabolic factors and liver function testsIRCT20191209045671N3Semnan University of Medical Sciences60
已完成
1 期
Empagliflozin in non alcoholic fatty liverDiabetic patient with non alcoholic fatty liver.Other specified inflammatory liver diseasesK75.8IRCT20150706023084N18Islamic Azad University30