NL-OMON49097已完成2 期
CV019-010: A Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of BMS-986259 in Stabilized Patients Hospitalized for Acute Decompensated Heart Failure - CV019-010: A study of BMS-986259 in patients with acute heart failure
Bristol-Myers Squibb0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Patients currently hospitalized for ADHF, regardless of Left Ventricular
- •Ejection Fraction (LVEF) 24 hours or greater since presentation to the
- •Emergency Room defined as the time of the first dose of IV diuretic
- •administered at the hospital, maximum of 8 days since presentation to ER and
- •before hospital discharge.
- •* Acute Decompensated Heart Failure is the main reason for admission and there
- •is no other potential cause for congestive symptoms leading to index
- •hospitalization (eg, concurrent pneumonia, acute COPD exacerbation)
- •* Dyspnea at rest or with minimal exertion upon presentation to ER, plus signs
- •and symptoms of fluid overload that require IV therapy with loop diuretics
- •* NT-proBNP greater than or equal to 1400 pg/mL OR BNP greater than or equal to
- •350 pg/mL upon presentation to the hospital; NT-proBNP greater than or equal
- •to 2000 pg/mL OR BNP greater than or equal to 500 pg/mL if Atrial Fibrillation
- •(AFib) present at presentation. For participants on Entresto, NT-proBNP should
- •* Patients must be hemodynamically stable, as assessed by the investigator, and
- •as defined by the following criteria:
- •- * 12 hours since the last dose change of IV loop diuretics (ie,
- •participants may still be on IV loop diuretics at randomization, as long as
- •dose is stable for 12 hours or greater).
- •- * 24 hours since last dose of positive inotropes.
- •- * 12 hours since the last dose of IV vasodilators.
- •- Absence of symptoms of hypotension (eg, dizziness, lightheadedness,
- •- Supine Systolic Blood Pressure (SBP) must remain within the following
- •range*, on at least 2 routine consecutive measurements, over the 12 hours
- •before randomization:
- •1.) Sentinel Group: SBP greater than or equal to 115 mmHg
- •2.) Main Group: SBP greater than or equal to 100 mmHg
- •* Males and Females at least 18 years of age
- •* Males who are sexually active with Woman of Child-Bearing Potential (WOCBP)
- •must agree to follow instructions for method(s) of contraception defined in the
- •protocol, during the study and for at least 6 days after the last dose of the
- •study treatment
- •* Female Participants:
- •- Are eligible to participate if they are not pregnant or breast
- •feeding and if they are not a WOCBP
- •- Women must have documented proof that they are not of childbearing
排除标准
- •* At randomisation Systolic Blood Pressure (SBP) less than 100 mmHg or greater
- •than 145 mmHg
- •* At randomisation Heart Rate (HR) greater than 120 bpm
- •* Acute cardiovascular condition other than HF decompensation either
- •contributing to hospitalisation or making the participant unstable, such as
- •acute MI/acute coronary syndrome, myocarditis, or arrhythmia with the exception
- •of atrial fibrillation if HR within criteria limit.
- •* Cardiogenic shock (defined as SBP below 90 mmHg, signs of end-organ
- •hypoperfusion plus need for intubation, mechanical circulatory support and
- •other life-sustaining emergency measures) at presentation to Emergency Room or
- •at any time before randomisation.
- •* History of heart or any other solid organ transplant or currently on the
- •transplant list.
- •* Recipient of ventricular assist devices.
- •* Use of any cardiac extracorporeal devices, within 12 weeks of study
- •randomisation. Cardiac Resynchronization Therapy Defibrillator (CRTD) and
- •pacemakers / Implantable Cardioverter-Defibrillator (ICDs) are allowed, if
- •implanted at least 4 weeks before randomization and no discharge within 4 weeks
- •prior to randomisation.
- •* Participants with contraindications to vasodilator therapy such as
- •restrictive or obstructive cardiomyopathy, severe mitral or aortic stenosis.
- •* Women cannot be pregnant or breastfeeding.
- •* Any major surgery within 12 weeks of study randomization.
- •* Suspected acute pulmonary disease such as pneumonia, exacerbation of asthma
- •or COPD or severe chronic, pulmonary disease (eg. severe COPD , pulmonary
- •fibrosis, patients with hypercapnia or requiring home oxygen or chronic
- •systemic steroids).
- •* Hereditary or idiopathic pulmonary hypertension.
- •* History of stroke, or transient ischemic attack (TIA) within the 30 days
- •prior to screening (according to the participants' records) or during screening.
- •* Acute coronary event within 30 days prior to screening or during screening
- •(myocardial infarction, acute coronary syndrome, or unstable angina; according
- •to the participants' records).
- •* Terminal non-cardiovascular disease such as cancer with a life expectancy for
- •less than 6 months.
- •* Severe liver disease such as cirrhosis with evidence of portal hypertension,
- •or acute viral hepatitis.
- •* Participant is on dialysis or history of chronic or intermittent dialysis or
- •ultrafiltration.
- •* Need for mechanical ventilation any time before screening or non-invasive
- •ventilation (CPAP, BiPAP) less than 2 hrs prior to screening.
- •* Inability to comply with restrictions and prohibited treatments as listed in
- •the protocol.
- •* Exposure to any investigational drug or placebo, including serelaxin; within
- •30 days of initial study drug administration or 4 months prior to the first
- •dose of investigational product, in case of exposure to long-acting biological
- •investigational drug.
- •* Persistent electrolytes abnormalities not corrected before randomization
- •- (1) A sodium concentration less than 130 or greater than 145 mEq/l
- •- (2) A potassium concentration less than 3.1 or greater than 5.5 mEq/l
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