NL-OMON46513已完成2 期
An Exploratory, Randomized, Double-blind, Placebo-controlled, Parallel Arm Trial of the Safety and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients with Worsening Heart Failure - PDY15079
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •-18 years of age or older.;-Patient admitted to the hospital or had urgent visit to emergency department or heart failure unit/clinic for Congestive Heart Failure, defined by:;-Presence of *2 of the following clinical signs and symptoms of congestion: jugular venous distension, pitting edema in lower extremities greater than trace, dyspnea, rales heard on auscultation, radiographic pulmonary congestion, weight gain above historical dry weight of at least 5 lbs (2.27 kg) and requiring treatment with IV diuretics (*2 bolus doses or continuous infusion).;-Estimated glomerular filtration rate (eGFR) *30 mL/min/1.73m^2 at the screening or randomization visit by the 4 variable Modification of Diet in Renal Disease (MDRD) equation.
- •-Transitioning from IV to oral diuretics and oral diuretic treatment has been prescribed or administered.
- •-Hemodynamically stable, defined as:
- •-SBP *100 mmHg with no requirement for IV inotropic therapy or IV vasodilators
排除标准
- •-History of Type 1 diabetes mellitus.;-Current admission or visit for Worsening HF that is clearly and primarily triggered by causes such as tachyarrhythmia (example: sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response > 130 beats per minute), acute coronary syndrome, pulmonary embolism, cerebrovascular accident, heart valve disorders (such as severe aortic stenosis), as determined by the Investigator.;- Clinically significant myocardial infarction (MI) within past 1 month as determined by Investigator and with objective evidence from ECG, and/or cardiac imaging and/or coronary angiography. Small isolated elevations in troponin that often accompany HF hospitalization are not an exclusion, nor are clinically significant MIs that have been revascularized without complications ;- patients who recently had or sceduled to have cardiac interventions may be eligible if:
- •-stable 48 hours post procedure and
- •-have diuretic treatment planned for the duration of treatment planned for the duration of treatment in this study.;- Current use of or recent suspension of digoxin therapy with high levels of digoxin (level should be obtained and must be <1.2 ng/mL) at screening.;-History of heart or kidney transplant.;- Diagnosis of hypertrophic obstructive cardiomyopathy.;- End-stage HF defined as requiring left ventricular assist device insertion, intra-aortic balloon placement (IABP), or any type of mechanical support during the study period.;- Use of any investigational drug(s) or prohibited therapy or sodium-glucose co-transporter 2 (SGLT2) inhibitor 5 half-lives prior to screening.;- Patients with moderate or severe respiratory, moderate and severe hepatic, neurological, psychiatric, active malignant tumor or other major systemic disease (including any diseases with evidence of malabsorption), making implementation of the protocol and/or the interpretation of the study results difficult.;- Known allergies, hypersensitivity, or intolerance to sotagliflozin or any inactive component of sotagliflozin or placebo (ie, microcrystalline cellulose, croscarmellose sodium [disintegrant], talc, silicon dioxide, and magnesium stearate [non-bovine]), unless the reaction is deemed irrelevant to the study by the PI.;- Laboratory findings at the Screening Visit:;-Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of the normal laboratory range (ULN) (1 repeat lab allowed);;-Total bilirubin >1.7 times the ULN (except in case of Gilbert*s syndrome) (1 repeat lab allowed);;-Amylase and/or lipase > 3 times the ULN (1 repeat lab allowed);- Patients with a severe or persistent in spite of optimal treatment genitourinary tract infection at time of randomization.;- Patient is the Investigator or any Sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.;- History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 3 months prior to the screening visit.;- Lower extremity diabetic complication (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization.
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