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

Debiopharm S.A.0 个研究点目标入组 260 人开始时间: 2009年12月7日最近更新: 2017年5月22日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Debiopharm S.A.
入组人数: 260

研究概览入排标准研究者记录与标识符相似试验

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.

研究者

发起方

Debiopharm S.A.

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