EUCTR2016-003586-26-NL进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients with Heart Failure and Impaired Systolic Function
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 49
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) Signed Written Informed Consent
- •a) Subjects will be required to provide a written informed consent.
- •2) Type of Participant and Target Disease Characteristics
- •a) Males and Females, ages 18 (or age of majority) or older
- •b) Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)c) Stable guideline directed therapy for heart failure including oral diuretics, ACEi, ARBs, ARNi, MRAs , and ß blockers as tolerated), with no dose changes of these medications in the past 2 weeks
- •d) Have screening values of NT pro-BNP = 125 pg/mL (15 pmol/L) or BNP = 35 pg/mL (10 pmol/L).
- •e) In sinus rhythm at the start of the infusion
- •3) Age and Reproductive Status
- •a) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.
- •b) Women must not be breastfeeding
- •c) Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 32 days after discontinuation (duration of study drug plus 30 days duration of one ovulatory cycle).
- •d) Males who are sexually active with WOCBP must agree to follow instructions for methods of contraception (Appendix 4) for total of 91 days after discontinuation (duration of study drug plus 90 days (duration of sperm turnover).
- •e) Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, but still must undergo pregnancy testing as described in this section. Investigators shall counsel WOCBP, and male participants who are sexually active with
- •WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, (Appendix 4 which have a failure rate of < 1% when used consistently and correctly.
- •Local laws and regulations may require use of alternative and/or additional contraception methods.
- •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 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1) Target Disease Exceptions
- •a) Systolic blood pressure (SBP) < 110 mm Hg at screening or pre-randomization
- •b) Heart rate < 50 beats per minute (bpm) or > 90 bpm at screening orpre-randomization
- •c) Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter before start of the infusion
- •d) Permanent paced rhythm (VVI, DDD or BiV pacing)
- •e) NYHA Class IV symptoms of heart failure
- •2) Medical History and Concurrent Disease
- •a) Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease as defined by AHA/ACC/ESC criteria. (Note: A restrictive mitral inflow pattern is not exclusionary)
- •b) Pericardial tamponade or constrictive pericarditis
- •c) Large post-MI LV aneurisms
- •d) Intra-cardiac thrombus
- •e) Prior mitral valve repair, mitral or aortic prosthesis of any type.
- •f) LV assist device or prior heart transplant
- •g) Hospitalized for acute decompensated heart failure in the previous month
- •h) Hospitalized with acute coronary syndrome, coronary evascularization or acute myocardial infarction during the previous 90 days prior to screening
- •i) Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening
- •j) Considered clinically unstable for any condition
- •k) Serious comorbid non cardiovascular disease in which the life expectancy of the subject is < 3 months
- •l) Liver disease defined as history of cirrhosis with evidence of portal hypertension such as varices, or encephalopathy, or total bilirubin > 3 mg/dL (> 51 µmol/L) or significant elevation of liver enzymes (AST, ALT > 3 times the upper limit of normal)
- •m) Prior solid organ transplant
- •3) Prior/Concomitant Therapy
- •a) Treatment with oral phosphodiesterase type 5 (PDE5) inhibitor sildenafil, vardenafil or avanafil within 24 hours of study drug infusion or treated with tadalafil within 4 days of study drug infusion
- •b) Treatment with intravenous inotropic therapy (dobutamine, milrinone, leveosimendan) in the previous month or planned treatment in next 3 months.
- •c) Current treatment with chronic oral, transdermal or sublingual nitrates, except at the discretion of the investigator and treating
- •physician, nitrates could be temporarily interrupted. In which case, an
- •interruption of 3 days is required prior to start of study drug.
- •4) Physical and Laboratory Test Findings
- •a) Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2
- •b) Have persistent abnormal serum electrolytes not resolved between screening and start of
- •the study drug infusion, as defined by any of the following:
- •i) A sodium (Na+) concentration < 130 or >145 mEq/L (mmol/L)
- •ii) A potassium (K+) concentration < 3.2 or >5.5 mEq/L (mmol/L)
- •c) Have severe anemia, as documented by a hemoglobin < 9 g/dL (< 5.59 mmol/L)
- •5) Allergies and Adverse Drug Reaction
- •a) Any history of allergic reaction to BMS-986231, or its components, Captisol® or potassium acetate.
- •b) Allergic reactions to organic nitrates
- •6) Other Exclusion Criteria
- •a) Prisoners or participants who are involuntarily incarcerated. (Note:
- •under certain specific circumstances a person who has been imprisoned
- •may be included or permitted to continue as a participant. Strict
- •conditions apply and Bristol-Myers Squibb's approval is required.
- •b) Participants who are compulsorily detained for treatment of either a
- •psychiatric or physical
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