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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003586-26 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/BMS-986231/NTG | Experimental | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
|
| Placebo/NTG/BMS-986231 | Experimental | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
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| NTG/Placebo/BMS-986231 | Experimental | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
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| NTG/BMS-986231/Placebo | Experimental | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
|
| BMS-986231/Placebo/NTG | Experimental | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HNO Donor | Drug | Infusion |
|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean SVI Derived From LVOT VTI at the End of the 5-hour Infusion of BMS-986231, Versus NTG | 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 |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Northwestern Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31168885 | Derived | Felker GM, Borentain M, Cleland JG, DeSouza MM, Kessler PD, O'Connor CM, Seiffert D, Teerlink JR, Voors AA, McMurray JJV. Rationale and design for the development of a novel nitroxyl donor in patients with acute heart failure. Eur J Heart Fail. 2019 Aug;21(8):1022-1031. doi: 10.1002/ejhf.1504. Epub 2019 Jun 6. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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49 participants assigned to treatment and 45 treated. Reasons not treated: 2 re-randomized; 1 randomized in error, screen failure; 1 no longer met study criteria.
Note: Study designed for all participants to enter all 3 arms (reassignment of arms occurs every period change).
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period. 3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG) Sequence of treatment for this group is as follows: PBO-drug-NTG |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2017 | May 6, 2020 |
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| BMS-986231/NTG/Placebo | Experimental | administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods |
|
|
| Nitroglycerin (NTG) | Drug | Infusion |
|
| Placebo | Other | 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 | 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 | 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 | 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 | 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 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Indiana University School of Medicine-Indianapolis | Indianapolis | Indiana | 46202-1218 | United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Duke Advanced Heart and Lung Failure Clinic | Durham | North Carolina | 27710 | United States |
| Inova Heart and Vascular Institute | Falls Church | Virginia | 22042 | United States |
| Local Institution | Nagoya | Aichi-ken | 466-8560 | Japan |
| Local Institution | Kawasaki | Kanagawa | 211-8533 | Japan |
| Local Institution | Suita-shi | Osaka | 5650871 | Japan |
| Local Institution | Groiningen | 9713GZ | Netherlands |
| Local Institution | Edinburgh | EH16 4SA | United Kingdom |
| Local Institution | Glasgow | G4 0SF | United Kingdom |
| Local Institution | Glasgow | G429LF | United Kingdom |
| Local Institution | Glasgow | G51 4TF | United Kingdom |
| Local Institution | Harrow | HA1 3UJ | United Kingdom |
| Local Institution | London | SE1 1YR | United Kingdom |
| Local Institution | London | sw17 0re | United Kingdom |
| Local Institution | London | SW3 6NP | United Kingdom |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| FG001 | Sequence 2 | Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period. 3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG) Sequence of treatment for this group is as follows: PBO-NTG-drug |
| FG002 | Sequence 3 | Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period. 3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG) Sequence of treatment for this group is as follows: NTG-PBO-drug |
| FG003 | Sequence 4 | Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period. 3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG) Sequence of treatment for this group is as follows: NTG-drug-PBO |
| FG004 | Sequence 5 | Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period. 3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG) Sequence of treatment for this group is as follows: drug-PBO-NTG |
| FG005 | Sequence 6 | Participants crossed-over from one therapy to the next following Day 1 treatment and a minimum 5-day washout period. 3 treatments were given via 1 of 6 different order sequences across 3 total treatment periods, 1 treatment per period. Treatments were as follows: Placebo (PBO) BMS-986231 (drug) Nitroglycerin (NTG) Sequence of treatment for this group is as follows: drug-NTG-PBO |
|
| Completed Period 1 (P1) |
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| Completed Period 2 (P2) |
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| COMPLETED | completed = finished Period 3 (P3) assigned treatment |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Inclusive of all treatments, all periods. Note: Participants crossed-over from either placebo, drug or NTG arm to the next (in various sequence) following Day 1 treatment and a minimum 5-day washout period, per arm. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period. | Posted | Mean | Standard Deviation | mL/m^2 | at the end of the 5-hour infusion |
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| Secondary | Mean SVI Derived From LVOT VTI at the End of the 5-hour Infusion of BMS-986231, Versus NTG | 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. | Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period. | Posted | Mean | Standard Deviation | mL/m^2 | at the end of the 5-hour infusion |
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| Secondary | Mean LVEF, Computed by Simpson's Method at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG | Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: LV ejection fraction | Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period. | Posted | Mean | Standard Deviation | Percentage of blood pumped from the LV | at the end of the 5-hour infusion |
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| Secondary | Mean Cardiac Power Index at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG | Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Mean LV power index | Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period. | Posted | Mean | Standard Deviation | watts per square meter (W/m^2) | at the end of the 5-hour infusion |
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| Secondary | Mean Diastolic Indices: E/A and E/e' Ratio at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG | Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Diastolic function | Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period. | Posted | Mean | Standard Deviation | Ratio | at the end of the 5-hour infusion |
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| Secondary | Mean Diastolic Indices: Annular e' Velocity at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG | Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: Diastolic function | Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period. | Posted | Mean | Standard Deviation | cm/sec | at the end of the 5-hour infusion |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean LV Global Longitudinal Strain, Computed Using STE at the End of the 5-hour Infusion of BMS-986231, Versus Placebo and NTG | Evaluate the effects of BMS-986231 on selected other left ventricular systolic and diastolic indices compared to placebo and NTG: LV global longitudinal strain | Intent to Treat (ITT) population: All randomized participants who started study drug infusion in at least one treatment period. | Posted | Mean | Standard Deviation | Percentage of blood pumped from the LV | at the end of the 5-hour infusion |
|
From first dose to 30 days post last dose (approximately 3 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (PBO) | Placebo-matching treatment. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO | 0 | 40 | 1 | 40 | 2 | 40 |
| EG001 | BMS-986231 | BMS-986231: 3 μg/kg/min for 10 min, followed by 6 μg/kg/min for 10 min, followed by 12 μg/kg/min for the rest of the 5-hour infusion. Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO | 0 | 42 | 0 | 42 | 12 | 42 |
| EG002 | Nitroglycerin (NTG) | NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO | 0 | 44 | 1 | 44 | 10 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 24, 2019 | May 6, 2020 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Nitroglycerin (NTG) | NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO |
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| OG002 | Nitroglycerin (NTG) | NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO |
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| OG002 | Nitroglycerin (NTG) | NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO |
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| OG002 | Nitroglycerin (NTG) | NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO |
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| OG002 | Nitroglycerin (NTG) | NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO |
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| OG002 | Nitroglycerin (NTG) | NTG: 20 μg/min for 10 min, followed by 40 μg/min for 10 min, followed by 80 μg/min for the rest of the 5-hour infusion Note: Participants crossed-over from one arm to the next following Day 1 treatment and a minimum 5-day washout period, per arm. Treatment was given via 1 of 6 different order sequences across 3 total treatment periods. Participant therapy sequence assignment varies as follows: PBO-drug-NTG, PBO-NTG-drug, NTG-PBO-drug, NTG-drug-PBO, drug-PBO-NTG, drug-NTG-PBO |
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