NCT03016325CompletedPhase 2
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function
Bristol-Myers Squibb25 sites in 2 countries329 target enrollmentStarted: January 13, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 329
- Locations
- 25
- Primary Endpoint
- Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion
Study Overview
Brief Summary
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Actively being hospitalized for acute decompensated heart failure
- •At least 1 administration of IV diuretic for the current episode
- •Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II
- •Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic
- •Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%
Exclusion Criteria
- •Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm
- •Have an active infection requiring IV anti-microbial treatment
- •Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening
- •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
- •Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)
- •Other protocol defined inclusion/exclusion criteria could apply
Arms & Interventions
Placebo Part 1 Cohort 1
Placebo Comparator
Intervention: Placebo (Drug)
Placebo Part 2 Cohort 2
Placebo Comparator
Intervention: Placebo (Drug)
Part 1 Cohort 1 HNO Donor
Experimental
Intervention: HNO Donor (Drug)
Part 2 Cohort 2 HNO Donor- high dose
Experimental
Intervention: HNO Donor (Drug)
Part 2 Cohort 2 HNO Donor- low dose
Experimental
Intervention: HNO Donor (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Clinically Relevant Hypotension up to 6 Hours After the End of Study Drug Infusion
Time Frame: From start of infusion up to 6 hours post end of infusion
Percentage of participants with clinically relevant hypotension, defined by systolic blood pressure (SBP) \< 90 mm Hg (confirmed by a repeated value \< 90 mm Hg) or symptoms of hypotension, up to 6 hours after the end of study drug infusion
Secondary Outcomes
- Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate(to 120 hours)
- Change in Troponin T From Baseline to Hour 24, 48, and 72(from baseline to Hour 24, 48, and 72)
- Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure(up to 120 hours (for AEs); up to 32 days (for SAEs))
- Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours(up to 120 hours)
- Number of Participants Who Discontinued Due to Hypotension(up to 120 hours (for AEs); up to 32 days (for SAEs))
- Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182(through 182 days)
- Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology(to 120 hours)
- Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L(to 120 hours)
- Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis(to 120 hours)
- Change in Vital Signs From Baseline to 120 Hours - Heart Rate(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion(to 120 hours)
- Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32(0, 24, 48, 72, 120 hour or discharge; Day 32)
- Percentage of Participants With Symptomatic Hypotension up to 6 Hours After the End of Study Drug Infusion(From start of infusion up to 6 hours post end of infusion)
- Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)(From start of infusion up to 6 hours post end of infusion)
- Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32(32 days)
- Change in Vital Signs From Baseline to 120 Hours - Blood Pressure(to 120 hours)
- Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration(to 120 hours)
- Change in Physical Measurements From Baseline to 120 Hours(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)(to 120 hours)
- Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72(Hours 6, 12, 24, 48, and 72)
- Change in Vital Signs From Baseline to 120 Hours - Temperature(to 120 hours)
- Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L(to 120 hours)
- Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion(to 120 hours)
Investigators
Study Sites (25)
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