A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function
July 24, 2020 updated by: Bristol-Myers Squibb
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi
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Nagoya, Aichi, Japan, 466-8560
- Local Institution
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Kanagawa
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Kawasaki, Kanagawa, Japan, 211-8533
- Local Institution
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Osaka
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Suita-shi, Osaka, Japan, 5650871
- Local Institution
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Groiningen, Netherlands, 9713GZ
- Local Institution
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Edinburgh, United Kingdom, EH16 4SA
- Local Institution
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Glasgow, United Kingdom, G4 0SF
- Local Institution
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Glasgow, United Kingdom, G429LF
- Local Institution
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Glasgow, United Kingdom, G51 4TF
- Local Institution
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Harrow, United Kingdom, HA1 3UJ
- Local Institution
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London, United Kingdom, SE1 1YR
- Local Institution
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London, United Kingdom, sw17 0re
- Local Institution
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London, United Kingdom, SW3 6NP
- Local Institution
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California
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Tustin, California, United States, 92780
- Orange County Research Center
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medicine
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Indiana
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Indianapolis, Indiana, United States, 46202-1218
- Indiana University School of Medicine-Indianapolis
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Womens Hospital
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Advanced Heart and Lung Failure Clinic
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Virginia
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Falls Church, Virginia, United States, 22042
- Inova Heart and Vascular Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Placebo/BMS-986231/NTG
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
|
Infusion
Other Names:
Infusion
Infusion
|
|
EXPERIMENTAL: Placebo/NTG/BMS-986231
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
|
Infusion
Other Names:
Infusion
Infusion
|
|
EXPERIMENTAL: NTG/Placebo/BMS-986231
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
|
Infusion
Other Names:
Infusion
Infusion
|
|
EXPERIMENTAL: NTG/BMS-986231/Placebo
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
|
Infusion
Other Names:
Infusion
Infusion
|
|
EXPERIMENTAL: BMS-986231/Placebo/NTG
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
|
Infusion
Other Names:
Infusion
Infusion
|
|
EXPERIMENTAL: BMS-986231/NTG/Placebo
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
|
Infusion
Other Names:
Infusion
Infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Stroke Volume Index (SVI) Derived From the Velocity Time Integral at the Left Ventricular Outflow Tract (LVOT VTI) at the End of the 5-hour Infusion of BMS-986231, Versus Placebo
Time Frame: at the end of the 5-hour infusion
|
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to placebo.
|
at the end of the 5-hour infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean SVI Derived From LVOT VTI at the End of the 5-hour Infusion of BMS-986231, Versus NTG
Time Frame: at the end of the 5-hour infusion
|
The objective is to evaluate the effects of BMS-986231 on the left ventricular (LV) systolic function by stroke volume index (SVI) assessed by echocardiography compared to NTG.
|
at the end of the 5-hour infusion
|
|
Mean LVEF, Computed by Simpson's Method at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
Time Frame: at the end of the 5-hour infusion
|
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: LV ejection fraction |
at the end of the 5-hour infusion
|
|
Mean Cardiac Power Index at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
Time Frame: at the end of the 5-hour infusion
|
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Mean LV power index |
at the end of the 5-hour infusion
|
|
Mean Diastolic Indices: E/A and E/e' Ratio at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
Time Frame: at the end of the 5-hour infusion
|
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Diastolic function |
at the end of the 5-hour infusion
|
|
Mean Diastolic Indices: Annular e' Velocity at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
Time Frame: at the end of the 5-hour infusion
|
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Diastolic function |
at the end of the 5-hour infusion
|
|
Mean LV Global Longitudinal Strain, Computed Using STE at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG
Time Frame: at the end of the 5-hour infusion
|
Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: LV global longitudinal strain |
at the end of the 5-hour infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 30, 2017
Primary Completion (ACTUAL)
May 10, 2019
Study Completion (ACTUAL)
May 10, 2019
Study Registration Dates
First Submitted
October 31, 2017
First Submitted That Met QC Criteria
November 29, 2017
First Posted (ACTUAL)
November 30, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 27, 2020
Last Update Submitted That Met QC Criteria
July 24, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV013-020
- 2016-003586-26 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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