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A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function

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ClinicalTrials.gov Identifier: NCT03357731
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

October 31, 2017
November 30, 2017
January 10, 2019
November 30, 2017
May 29, 2019   (Final data collection date for primary outcome measure)
Left Ventricle Stroke Volume Index (SVI) [ Time Frame: 5 hours ]
Same as current
Complete list of historical versions of study NCT03357731 on ClinicalTrials.gov Archive Site
  • Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 5 hours ]
    computed by Simpson's method
  • Mean Cardiac Power Index [ Time Frame: 5 hours ]
  • The ratio of the time velocity integral of early-to-late ventricular filling (E/A) [ Time Frame: 5 hours ]
  • Mean LV global longitudinal strain [ Time Frame: 5 hours ]
    computed using speckle-tracking echocardiography (STE)
Same as current
Not Provided
Not Provided
 
A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
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
The purpose of this study is to evaluate the effects of BMS-986231 on systolic and diastolic parameters in patients with heart failure and low ejection fraction.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Heart Failure
  • Cardiac Failure
  • Reduced Ventricular Ejection Fraction
  • Drug: HNO Donor
    Infusion
    Other Name: BMS-986231
  • Drug: Nitroglycerin (NTG)
    Infusion
  • Other: Placebo
    Infusion
  • Experimental: Placebo/BMS-986231/NTG
    administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
    Interventions:
    • Drug: HNO Donor
    • Drug: Nitroglycerin (NTG)
    • Other: Placebo
  • Experimental: Placebo/NTG/BMS-986231
    administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
    Interventions:
    • Drug: HNO Donor
    • Drug: Nitroglycerin (NTG)
    • Other: Placebo
  • Experimental: NTG/Placebo/BMS-986231
    administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
    Interventions:
    • Drug: HNO Donor
    • Drug: Nitroglycerin (NTG)
    • Other: Placebo
  • Experimental: NTG/BMS-986231/Placebo
    administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
    Interventions:
    • Drug: HNO Donor
    • Drug: Nitroglycerin (NTG)
    • Other: Placebo
  • Experimental: BMS-986231/Placebo/NTG
    administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
    Interventions:
    • Drug: HNO Donor
    • Drug: Nitroglycerin (NTG)
    • Other: Placebo
  • Experimental: BMS-986231/NTG/Placebo
    administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
    Interventions:
    • Drug: HNO Donor
    • Drug: Nitroglycerin (NTG)
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
Same as current
May 29, 2019
May 29, 2019   (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)
  • Stable guideline directed therapy for heart failure including oral diuretics, ACEi, ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these medications in the past 2 weeks
  • Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10 pmol/L)

Exclusion Criteria:

  • Systolic blood pressure (SBP) < 110 mm Hg at screening or pre-randomization
  • Heart rate < 50 beats per minute (bpm) or > 90 bpm at screening or pre-randomization
  • Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter
  • Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2
  • Ventricular assist device or prior heart transplant
  • Prior solid organ transplant
  • Body weight < 45 kg or ≥ 140 kg
  • Low quality echocardiographic visualization windows and image acquisition
  • Permanent paced rhythm (VVI, DDD or BiV pacing)

Other protocol defined inclusion/exclusion criteria could apply

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Japan,   Netherlands,   United Kingdom,   United States
 
 
NCT03357731
CV013-020
2016-003586-26 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP