EUCTR2020-000885-40-RO进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study on the Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock (SEISMiC)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •1.Clinical presentation consistent with SCAI Stage B precardiogenic shock caused by acute decompensation of chronic
- •systolic heart failure (due to arterial hypertension, ischemic heart
- •disease or dilated cardiomyopathy), without evidence for an
- •acute coronary syndrome.
- •2. Signed informed consent form (ICF);
- •3. Males and females, 18 to 85 years of age (inclusive);
- •4. An admission within 36 hours prior to randomization for ADHF
- •episode, defined as:
- •a. Dyspnea, at rest or with minimal exertion,
- •b. Congestion on chest x-ray or lung US with BNP = 400 pg/mL
- •or NT-proBNP = 1400 pg/mL.
- •Elective admissions for medications tune up or procedures do not
- •qualify as an ADHF admission.
- •5. History of left ventricular ejection fraction (LVEF) = 40%;
- •6. Persistent hypotension defined as
- •a. SBP between 75 and 90 mmHg for at least 2 hours prior to
- •b. SBP doesn’t decrease by > 7 mmHg on two separate
- •measurements during the last 2 hours prior to randomization;
- •7. Heart rate 75 to 150 bpm. If the subject is on a beta-blocker, the
- •range is 60 to 150 bpm;
- •8. Echocardiogram during index hospitalization confirming
- •ejection fraction = 40% and no evidence of other pathology to confound interpretation of cardiac physiology (eg, pericardial
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Cardiogenic shock of SCAI stage C or worse
- •2. Cardiogenic shock due to any other condition besides acute
- •decompensation of chronic heart failure.
- •3. Any of the following in the past 30 days: acute coronary
- •syndrome, coronary revascularization, MI, CABG, or
- •percutaneous coronary intervention;
- •4. Current (within 6 hours of Screening) or planned (within 6 hours
- •after randomization) treatment with positive inotropic agents or
- •vasopressors, renal support including ultrafiltration, or
- •mechanical circulatory, ventilatory or renal support (intra-aortic
- •balloon pump, endotracheal intubation, mechanical ventilation,
- •or any ventricular assist device);
- •5. Venous Lactate > 2 mmol/L;
- •6. History of heart transplant or UNOS priority 1a heart transplant
- •7. Ongoing treatment with digoxin (if digoxin was stopped before
- •signing the ICF and the digoxin plasma level is < 0.5 ng/ml, the
- •patient may be enrolled);
- •8. Severe renal impairment (eGFR < 30 ml/min, calculated by the
- •MDRD formula);
- •9. Hypersensitivity to the study medication and its excipients
- •(including known lactose hypersensitivity) or any related
- •medication;
- •10. Stroke or TIA within 3 months;
- •11. Incomplete revascularization (patients with ischemic heart
- •disease have to have had a catheterization in the last year
- •demonstrating that the main coronary arteries are well
- •revascularized);
- •12. Any significant valvular disease (including moderate or severe
- •valvular disease, such as severe aortic stenosis or regurgitation);
- •severe tricuspid or mitral regurgitation;
- •13. Primary hypertrophic or restrictive cardiomyopathy or systemic
- •illness known to be associated with infiltrative heart disease;
- •14. Admission for AHF triggered primarily by a correctable etiology
- •such as significant arrhythmia (inclusive of atrial fibrillation as
- •the main reason for admission), infection, severe anemia, acute
- •coronary syndrome, pulmonary embolism, exacerbation of
- •COPD, planned admission for device implantation, or overdiuresis as a cause of hypotension;
- •15. Pericardial constriction or active pericarditis;
- •16. Life-threatening ventricular arrhythmia or implantable
- •cardioverter defibrillator (ICD) shock within the past month or
- •history of sudden death within 6 months;
- •17. Cardiac resynchronization therapy (CRT), ICD, or pacemaker
- •implantation within the past month;
- •18. Sustained ventricular tachycardia in the last 3 months with no
- •defibrillator;
- •19. Cor pulmonale or other causes of isolated right-sided HF or not
- •related to left ventricular dysfunction;
- •20. Acute respiratory distress syndrome;
- •21. Suspected sepsis; fever > 38° or active infection requiring IV
- •antimicrobial treatment;
- 另有 10 项未显示
研究者
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