EUCTR2017-002774-39-NL进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Written informed consent.
- •-18 years of age or older.
- •-Patient admitted to the hospital or had urgent visit to emergency department or heart failure unit/clinic or infusion center for Congestive Heart Failure (CHF), 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 intravenous (IV) diuretics
- •-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.
- •-Female subject must use a double contraception method during the study including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
- •-Male participants, unless vasectomized and confirmed sterile by sperm analysis, must use condoms during the study and refrain from donating sperm up to 90 days after the day of last dose.
- •If the patient has a female partner of childbearing potential, the patient must wear a condom and female partner must use at least 1 highly effective method of birth control during the study treatment period and the Follow-up period.
- •-Transitioning from IV to oral diuretics, and oral diuretic treatment has been prescribed or administered.
- •-Hemodynamically stable, defined as systolic blood pressure (SBP) >100 mmHg with no requirement for IV inotropes or IV vasodilators.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 144
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •-History of Type 1 diabetes mellitus.
- •-Appears unlikely or unable to participate in the required study procedures, as assessed by the study Investigator, study coordinator, or designee (ex: clinically-significant psychiatric, addictive, or neurological disease), or sectioned due to an official or court order.
- •-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 scheduled to have cardiac interventions may be eligible if:
- •- Stable 48 hours post procedure, and
- •- Have diuretic 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.
- •- Pregnancy (demonstrated by serum pregnancy test at screening), breast-feeding, or inability or refusal to undergo pregnancy testing.
- •- Use of any investigational drug(s) or prohibited therapy or sodium-glucose co-transporter 2 (SGLT2) 5 half-lives prior to screening.
- •- Patients with moderate or severe respiratory, 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 Subinvestigator, 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
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