CTRI/2020/11/029176招募中4 期
A prospective multicenter randomized open label active controlled study to assess effect of Remogliflozin on biomarkers of heart failure compared to Empagliflozin in patients of type 2 diabetes mellitus with chronic heart failure.
Sengupta Hospital and Research Institute12 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年11月20日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- Mean percentage change from baseline in NT-proBNP level
研究概览
简要总结
This is a prospective, multicenter, randomized open-label, active controlled study. 250 patients of T2DM with CHF will be enrolled in the study. Patients would be randomised under 2 arms- Remogliflozin and Empagliflozin and would be followed for 24 weeks. Mean change in NT proBNP, changes in ECHO parameters, NYHA functional classification will be evaluated from baseline till Week 24
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults (≥ 18 years) of either gender diagnosed with Type-2 Diabetes Mellitus more than 6 months back
- •Having uncontrolled glycaemia (HbA1c >6.5 & <9.0%) with no change in anti-diabetic treatment therapy since last 8 weeks
- •With comorbid Chronic heart failure diagnosed at least 3 months prior to screening & in NYHA HF Class I to III during screening) without change in NYHA functional classification prior to randomization
- •Having reported reduced EF (defined as LVEF <40%) as per local reading (obtained under stable condition by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT) measured within 6 months from the screening visit.
- •Having elevated NT-proBNP levels >600 pg/mL (or >1200 pg/mL in patients with AF) analysed at central Appropriate dose of medical therapy (such as ACEi, ARB, β-blocker, oral diuretics, MRA, ARNI, ivabradine) and/or appropriate device therapy, consistent with prevailing CV guidelines & local practice, stable for at least 3 week prior to Visit 1(screening) and during screening period until Visit 2 (Randomisation) with the exception of diuretics stable for only one week prior to Visit 2 to control symptoms.
- •Patients who understand & willing to comply with study requirements and provide written informed consent for participation.
排除标准
- •Patients who are being treated or have been treated with SGLT2i in past 12 weeks
- •Patients with evidence of Myocardial infarction, coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA in past 12 weeks prior
- •Heart transplant recipient, or listed for heart transplant implanted left ventricular assist device (LVAD) at screening
- •Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy, induced by chemotherapy or peripartum or known pericardial constriction
- •Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial in the investigator’s opinion
- •Acute decompensated HF (exacerbation of chronic HF) requiring IV diuretics, IV, inotropes, or i.v. vasodilators, or LVAD within 1 week from discharge to Visit 1 (Screening) and during screening period until Visit 2 (Randomisation)
- •Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 1(Screening)
- •Untreated ventricular arrhythmia with syncope in patients without ICD documented within the 3 months prior to Visit 1
- •Implanted cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) within 3 months prior to Visit 1, or if there is an intent to implant ICD or CRT within 6 months of visit 2
- •Symptomatic bradycardia or second or third degree heart block without a pacemaker after adjusting beta-blocker therapy, if appropriate
- •Systolic blood pressure (SBP) ≥ 180 mmHg at Visit
- •If SBP >150mmHg and <180mmHg at Visit 2, the patient should be receiving at least 3 antihypertensive drugs
- •Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 or Visit 2
- •Type 1 diabetes mellitus
- •History of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack ≤6 months prior to screening
- •Patients with eGFR <60 ml/min/1.73 m2
- •Patients with severe organ system disorders viz.
- •Hepatic, Renal, Neoplastic, Neurological or Psychiatric disorders.
- •Patients with planned surgery in next 24 weeks or has undergone major operative procedure in past 3 months
- •CHF (NYHA functional classification IV)
- •Patients with malnutrition, starvation, irregular eating pattern, lack of dietary intake, or debilitation or with a gastrointestinal disorder, such as diarrhea or vomiting, or Gastrointestinal surgery that could interfere with trial medication absorption in the investigator’s opinion
- •Patients with low or high body weight (BMI <18.5 kg/m2 or >45 kg/m2)
- •History of hypersensitivity to ingredients of SGLT2 inhibitors
- •Pregnant or suspected pregnancy in females, Lactating females & Patients of child bearing potential not willing to use effective non-hormonal method of contraception
- •Considered inappropriate for the study by investigators due to other reasons.
结局指标
主要结局
Mean percentage change from baseline in NT-proBNP level
时间窗: After 24 weeks of treatment
次要结局
- Mean percentage change from baseline in NT-proBNP level(After 4 and 12 weeks of treatment)
- Incidence of treatment emergent adverse events (TEAEs) assessed by any abnormal symptom, clinical signs or laboratory value(24 weeks)
- Mean change from baseline in ECHO parameters (LV Size and Volume, LA size and Volume, E/e’, LVEF, LV GLS, Grade of Diastolic dysfunction, PA pressure)(After 24 weeks of treatment)
- Change in proportion of patients in NYHA functional classification(From baseline to 12 weeks and 24 weeks)
- Proportion of patients with incidence of any major adverse CV events viz. non-fatal MI, non-fatal stroke, hospitalization for HF, CV-related death(24 weeks)
- Mean change from baseline in HbA1c, FPG levels, PPG levels, Body weight, Waist circumference(Week 12 and 24)
- Proportion of patients achieving good glycemic control (HbA1c≤7%)(After 24 weeks)
- Mean change from baseline in Lipid profile, Systolic and diastolic blood pressure(Week 12 and 24)
- Mean change from baseline renal function parameters (eGFR, UPCR, Sr. Creatinine, Sr. BUN, Sr Uric acid)(24 weeks)
研究者
研究点 (12)
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