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OpenTrials
Completed

NCT Number: NCT03016325

Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, CABA, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Treatment and study plan

HNO Donor

Drug

Infusion

Other names: BMS-986231

Placebo

Drug

Infusion

Primary outcomes

  1. 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

  1. Change in NT-proBNP From Baseline to Hour 24, 48, 72, 120 or Discharge (Whichever Comes First), and at Day 32

    Time frame: 0, 24, 48, 72, 120 hour or discharge; Day 32

    Assess the effect of BMS-986231 on NT-proBNP (N-terminal prohormone of brain natriuretic peptide)

  2. Change in Participant-reported Resting Dyspnea From Baseline Through Hour 72

    Time frame: Hours 6, 12, 24, 48, and 72

    Endpoint was measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) obtained at baseline, and Hours 6, 12, 24, 48, and 72.

    Participants were asked to report their absolute current severity of dyspnea on an 11-point numerical rating scale (NRS; range 0 to 10).

    The numerical rating scale (NRS) was used to assess the degree of dyspnea (breathlessness), measured using an 11-point scale provided by the Sponsor.

    A score of 0 represents "I am not breathless at all" and 10 represents "I am the most breathless I can possibly imagine".

  3. Percentage of Participants With Symptomatic 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

    The percentage of participants experiencing symptoms of hypotension up to 6 hours post-treatment was reported for each arm.

  4. Percentage of Participants With SBP < 90 mm Hg (Confirmed by a Repeated Value)

    Time frame: From start of infusion up to 6 hours post end of infusion

    The percentage of participants experiencing SBP < 90 mm Hg (confirmed by a repeated value) up to 6 hours post-treatment was reported for each arm.

  5. Number of Participants With a Serious Adverse Events (SAE) Assessed up to Day 32

    Time frame: 32 days

    Number of participants who experienced an in-study SAE.

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0 Included serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.

  6. Number of Participants Who Discontinued Due to Hypotension

    Time frame: up to 120 hours (for AEs); up to 32 days (for SAEs)

    Number of participants who discontinued study treatment due to hypotension.

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

    Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.

    Hypotension defined as systolic blood pressure (SBP) < 90 mmHg.

  7. Number of Participants Who Discontinued, Experienced a Down-titration or Dose Interruption Due to Decreased Blood Pressure

    Time frame: up to 120 hours (for AEs); up to 32 days (for SAEs)

    Number of participants who discontinued study treatment, experienced a down-titration (dose reduction) or dose interruption due to decreased blood pressure/hypotension are reported below.

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

    Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment and serious adverse events with onset time from the start of study treatment, up to and including 32 days after the start of study treatment.

    If the participant experienced systolic blood pressure (SBP) < 95 mm Hg, without symptoms related to hypotension, the measurement was repeated within 15 minutes. If the SBP remained < 95 mm Hg, the dose reduction occurred.

  8. Number of Participants With an Adverse Event (AE) Assessed up to 120 Hours

    Time frame: up to 120 hours

    Number of participants who experienced an in-study AE.

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

    Included nonserious adverse events with onset time from the start of study treatment, up to and including 120 hours after the start of study treatment.

  9. Number of Participants Who Died (All- Cause and Cardiovascular-related) Through Day 182

    Time frame: through 182 days

    Number of participants who died (all- cause and CV related) through Day 182.

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

    CV=Cardiovascular

  10. Change in Troponin T From Baseline to Hour 24, 48, and 72

    Time frame: from baseline to Hour 24, 48, and 72

    Baseline = Last non-missing result with a collection date-time less than or on the date-time of the start of infusion of study drug

  11. Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Hematology

    Time frame: to 120 hours

    Number of participants who experienced an in-study Hematology marked laboratory abnormality (reported in > 5% of total participants).

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

  12. Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Chemistry

    Time frame: to 120 hours

    Number of participants who experienced an in-study Chemistry marked laboratory abnormality (reported in > 5% of total participants).

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

  13. Number of Participants With Marked Laboratory Abnormality Assessed to 120 Hours - Urinalysis

    Time frame: to 120 hours

    Number of participants who experienced an in-study Urinalysis marked laboratory abnormality (reported in > 5% of total participants).

    Medical Dictionary for Regulatory Activities (MedDRA) version: 22.0

  14. Change in Vital Signs From Baseline to 120 Hours - Blood Pressure

    Time frame: to 120 hours

    The change in baseline for vital signs was reported for each arm.

  15. Change in Vital Signs From Baseline to 120 Hours - Heart Rate

    Time frame: to 120 hours

    The change in baseline for vital signs was reported for each arm.

  16. Change in Vital Signs From Baseline to 120 Hours - Respiratory Rate

    Time frame: to 120 hours

    The change in baseline for vital signs was reported for each arm.

  17. Change in Vital Signs From Baseline to 120 Hours - Temperature

    Time frame: to 120 hours

    The change in baseline for vital signs was reported for each arm.

  18. Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - Mean Heart Rate

    Time frame: to 120 hours

    The change in baseline for ECGs was reported for each arm.

  19. Change in Electrocardiograms (ECGs) From Baseline to 120 Hours - PR, QT, QTcF Intervals and QRS Duration

    Time frame: to 120 hours

    The change in baseline for ECGs was reported for each arm.

  20. Change in Physical Measurements From Baseline to 120 Hours

    Time frame: to 120 hours

    The change in baseline for physical measurements was reported for each arm.

  21. Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^9 Cells/L

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

  22. Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - g/L

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

  23. Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mmol/L

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

  24. Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - U/L

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

  25. Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - mg/dL

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

  26. Change in Laboratory Assessments From Baseline to 120 Hours, Main Study Cohorts Only - x10^12 c/L

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Main study cohorts only.

  27. Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Protein (Nmol/L)

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

  28. Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Creatinine (µmol/L)

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

  29. Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Cystatin (mg/L)

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

  30. Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Potassium Excretion

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

  31. Change in Laboratory Assessments From Baseline to 120 Hours, Japan Cohort Only - Percentage Fractional Sodium Excretion

    Time frame: to 120 hours

    The change in baseline for laboratory assessments was reported for each arm of the Japan cohort only.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: STANDUP AHF

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2017
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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