EUCTR2006-002403-13-LT进行中（未招募）1 期
A Phase 3, Randomized, Double-blinded, Placebo-controlled Study of Ularitide in the Treatment of Subjects with Acute Decompensated 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
- 3,000
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) Males and females = 18 years.
- •2) Unplanned hospitalization for ADHF.
- •3)Randomization within 24 hours after presentation to emergency department or hospital for ADHF.
- •4) Dyspnea at rest as assessed by the subject. Subject must have the ability to interpret and report self-assessed dyspnea
- •5) At least 1 of the following 2 criteria:
- •Prior medical history of CHF (eg, prior hospitalization for CHF) or left ventricular ejection fraction <40%, as determined by appropriate imaging techniques, such as echocardiography, nuclear scintigraphy, or contrast left ventriculography in the past 12 months.
- •Clinical evidence (at screening) of heart failure, including abnormal jugular venous pressure (JVP) (eg, >8 cm above the clavicle, assessed at 45°angle), rales or crackles more than a third above bases, or 2+ lower extremity edema.
- •6) Radiographic evidence (at screening) of pulmonary congestion (eg, redistribution, alveolar or interstitial edema, or pleural effusions).
- •7) On optimal background therapy for ADHF (as determined by the investigator); subjects are required to have received, at a minimum, at least one hour of oxygen supplementation and at least one dose of IV furosemide at a minimum dose of 40 mg (or another diuretic at a comparable dose; eg, 2 mg bumetanide or 20 mg torsemide), with the last bolus being delivered >2 hours before study drug administration is initiated.
- •8) If subject received IV opiate, the last dose should have been >3 hours before administration of study drug.
- •9) If the subject is a woman of potential childbearing age, documentation of a negative urine pregnancy test result within 24 hours prior to randomization.
- •10) Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).
- •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
- •1) Breathing rate <18 breaths per minute (measured during 60 seconds).
- •2) A systolic blood pressure (SBP) less than or equal to 110 mmHg or >200 mmHg within an hour before randomization, or SBP <120 mmHg for subjects receiving intravenous (IV) inotropics or vasodilators. A SBP <90 mmHg any time before randomization. (Subjects on baseline IV inotropes or vasodilators must be on a stable dose for =3 hours prior to randomization.)
- •3) Brain natriuretic peptide (BNP) <400 pg/mL or NT pro-BNP <1200 pg/mL, anytime from initial presentation to hospital to randomization.
- •4) Active ongoing myocardial ischemia, hospitalization for acute myocardial infarction, or administration of thrombolytic therapy in the last 30 days.
- •5) Any cardiogenic shock (SBP <90 mmHg with signs or symptoms of organ hypoperfusion) from initial presentation to randomization.
- •6) Body temperature = 38ºC.
- •7) Acute unstable clinical condition such as a hemodynamically significant arrhythmia or a persistent heart rate =130 bpm or is refractory to treatment (at the time of screening), or any unstable heart failure syndrome requiring any mechanical-assist device or emergency surgery.
- •8) Acute decompensated heart failure associated with endocrine, metabolic, or drug-related toxicity.
- •9) Percutaneous coronary intervention, coronary artery bypass graft surgery, other cardiac surgery, or major noncardiac surgery within 90 days prior to randomization.
- •10) Any volume depletion or severe electrolyte imbalance.
- •11) Anemia (hemoglobin <10 mg/dL or hematocrit <30%).
- •12) Significant acute or chronic respiratory disorder (eg, severe chronic obstructive pulmonary disease) or primary pulmonary hypertension with baseline dyspnea that may interfere with the ability to interpret dyspnea assessments or hemodynamic measurements.
- •13) For subjects with concomitant invasive hemodynamic monitoring (ie, pulmonary artery catheter monitoring): Baseline PCWP of = 20 mmHg.
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