EUCTR2008-003531-21-PL进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled parallel-group phase IIb study of the safety and efficacy of istaroxime over 24 hours at three doses in acute decompensated heart failure patients. The IGNITE Trial. - IGNITE Trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 260
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
- •Screening Inclusion Criteria:
- •1. Male or female patients =18 years.
- •2. Enrolled into the study during the first 48 hours of hospitalization.
- •3. Admission for ADHF defined as dyspnea at rest or orthopnea, with or without chest x-ray findings of pulmonary congestion.
- •4. Systolic blood pressure = 120 mmHg.
- •5. Ejection fraction (EF) = 35 % by any method (to be performed if not measured within the last 12 months).
- •6. Signed informed consent.
- •Randomization Inclusion Criteria:
- •1.Persistence of ADHF signs (JVD, pulmonary rales, peripheral edema) despite initial treatment with i.v. diuretics and/or vasodilators.
- •2.Cardiac index = 2.5 L/min/m².
- •3.Pulmonary capillary wedge pressure = 20 mmHg: 2 consecutive determinations at 30 minute intervals should not exceed a maximum of 10% variability; if the first 2 consecutive determinations fail to show the required stability, further determinations are allowed at the same interval within a maximum of 2 hours of evaluation. If stability is not demonstrated by 2 consecutive determinations within the 2-hour period, the patient will be excluded from the study.
- •4.Systolic BP comprised between 85 and 120 mmHg (limits included) without signs or symptoms of hypoperfusion including cardiogenic shock, cold extremities and peripheral vasoconstriction, oliguria/anuria, signs of cerebral hypoperfusion such as confusion.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Screening Exclusion Criteria:
- •1. Positive pregnancy test in females of childbearing potential.
- •2. Systolic blood pressure < 85 mmHg or > 120 mmHg.
- •3. Oral treatment with digoxin within one week before current hospitalization.
- •4. Any inotrope administered during the current hospitalization (e.g. dobutamine, dopamine, milrinone, levosimendan, digoxin, enoximone).
- •5. Presence of cardiogenic shock or its occurrence within the past month.
- •6. Acute coronary syndrome within the past 3 months.
- •7. Coronary artery bypass graft or percutaneous coronary intervention within the past month.
- •8. Stroke within the past 6 months.
- •9. Primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease.
- •10. Presence of signs or symptoms of uncontrolled hyperthyroidism or hypothyroidism.
- •11. Cor pulmonale or other causes of right-sided HF not related to left ventricular dysfunction.
- •12. Pericardial constriction or active pericarditis.
- •13. Atrial fibrillation with uncontrolled HR (HR > 100 beats per minute (bpm)).
- •14. Life threatening ventricular arrhythmia or ICD (implantable cardioverter defibrillator) shock within the past month.
- •15. Presence of a CRT (cardiac resynchronization therapy), ICD or pacemaker devices implanted within the past month.
- •16. Second or third degree atrio-ventricular block without pacemaker.
- •17. Valvular disease as the primary cause of HF.
- •18. Hemodynamic support devices.
- •19. Need for mechanical ventilation.
- •20. Acute respiratory distress syndrome or ongoing sepsis.
- •21. Terminal illness other than HF with expected survival less than 1 year.
- •22. Participation in another interventional study within the past 30 days.
- •23. The following laboratory exclusion criteria must be verified based on results obtained within the last 24 hours of the screening period prior to pulmonary arterial catheter (PAC) insertion:
- •a. Serum creatinine > 2.5 mg/dL (> 221 µmol/L),
- •b. Aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 x upper limit of normal,
- •c. Hemoglobin (Hb) < 10 g/dL,
- •d. International normalized ratio (INR) > 1.4 in patients not receiving anticoagulant therapy,
- •e. Platelet count < 100,000/µL,
- •f. Brain natriuretic peptide value < 500 pg/mL or NT-proBNP < 2000 pg/mL.
- •Randomization Exclusion Criteria:
- •1. Any inotrope administered during the current hospitalization period (e.g. dobutamine, dopamine, milrinone, levosimendan, digoxin, enoximon).
- •2. Heart rate > 120 bpm or < 50 bpm.
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