EUCTR2020-000885-40-PL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
- 90
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 pre-cardiogenic 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 of 75 to 90 mmHg (Part A) or 70 to 100 mmHg (Part B) for = 2 hours prior to Screening;
- •b. Stable SBP, defined as no decrease in SBP 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 effusion).
- •9. Subject is monitored by a PAC at the time of randomization (Part B only).
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
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 60 days: acute coronary syndrome, coronary revascularization, MI, CABG, or percutaneous coronary intervention;
- •4. Current (within 6 hours of Screening) or anticipated need for 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 listing
- •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. Active coronary ischemia;
- •12. Any significant valvular disease (including any moderate or severe valvular stenosis, moderate or severe aortic or pulmonary regurgitation, or 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 over-diuresis as a cause of hypotension;
- •15. Pericardial constriction or active pericarditis;
- •16.Life-threatening ventricular arrhythmia, uncontrolled arrythmia, or implantable cardioverter defibrillator (ICD) shock or history of sudden death within 6 months;
- •17.Cardiac resynchronization therapy (CRT), ICD, ablation, or pacemaker implantation (or planned implantation) within the past 3 months;
- •18. Sustained ventricular tachycardia in the last 3 months with no defibrillator;
- •19. Sustained hypotension (SBP < 70 mmHg) for at least 30 minutes from the time of arrival to the hospital;
- •20. Severe pulmonary disease or cor pulmonale or other causes of isolated right-sided HF or not related to left ventricular dysfunction;
- •21. Acute respiratory distress syndrome;
- •22. Suspected sepsis; fever > 38° or active infection requiring IV antimicrobial treatment;
- •23. Body weight < 40 kg or = 150 kg;
- •24. Laboratory exclusions:
- •a. Hemoglobin < 9 g/dl,
- •b. Platelet count < 100,000/µl,
- •c. Serum potassium > 5.3 mmol/l or < 3.5 mmol/l;
- •25. A life expectancy < 3 months based on the judgment of the investigator;
- •26. Uncontrolled thyroid disease;
- •27. Pregnant or breast-feeding;
- •28. Ongoing drug or alcohol abuse;
- •29. Participation in another interventional study within the past 30 days.
研究者
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