Trial · NCT03730961
An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
NCT03730961, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2021-01-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic. Trials, record NCT03730961. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03730961
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
- NCT number
- NCT03730961
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Cardiac Failure, Myocardial Failure, Congestive Heart Failure, Heart Decompensation
- Interventions
- BMS-986231, Furosemide, Placebo
- First posted
- 2018-11-05
- Last updated
- 2021-02-26
- Other registries' IDs
- eudract:2018-000970-31
- Results first posted
- 2021-01-26
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | 4 hours | The total volume of urinary output 4 hours after 40 mg furosemide bolus given to participants with HFrEF while on BMS-986231 compared to placebo: absolute difference in total volume and % change from placebo. Sequence 1: Placebo in period 1, drug in period 2 Sequence 2: Drug in period 1, placebo in period 2 |
| Secondary | FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo | Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours | Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo. Fractional Excretion Na = ((Urine Sodium \* Plasma Creatinine) / (Plasma Sodium \* Urine Creatinine)) \* 100 |
| Secondary | FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo | Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours | Secondary efficacy analyses was performed using the randomized population. The FeNa, FeK, furosemide urinary and plasma concentration and the ratio of urinary sodium to urinary furosemide was calculated at each time point over 4-hour urine/plasma collection after a bolus injection of 40 mg furosemide while receiving BMS-986231 or placebo. Fractional Excretion K = ((Urine Potassium \* Plasma Creatinine) / (Plasma Potassium \* Urine Creatinine)) \* 100 |
| Secondary | Furosemide Urinary Concentrations | Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours | Summary of urine recovery by interval, measured by amount excreted. |
| Secondary | Furosemide Plasma Concentrations | Day 1: 4, 5, 6, 8, 10 hours | Summary of plasma concentrations by interval. |
| Secondary | Ratio Urinary Sodium (Na) to Urinary Furosemide at 8 Hours Post-start Infusion | 0-4 hours after furosemide | Summary of urinary concentrations 0-4 hours after furosemide Ratio = Cumulative Sodium Excretion / Cumulative Furosemide in Urine |
| Secondary | Number of Participants With Clinically Relevant Hypotension | up to 8 hours | Clinically relevant hypotension is defined as systolic blood pressure (SBP) \< 90 mmHg or symptomatic hypotension during infusion |
| Secondary | Number of Participants With an Adverse Event (AE) | up to 8 days | Clinically relevant hypotension is defined as systolic blood pressure (SBP) \< 90 mmHg or symptomatic hypotension during infusion |
| Secondary | Number of Participants With an Abnormal Clinical Laboratory Value | from first dose to 30 days post-last dose (ca. 5-8 weeks) | Number of participants who experienced an in-study abnormal clinical laboratory event under the category of Hematology, Chemistry or Urinalysis. |
| Secondary | Change From Baseline in Vital Signs - Blood Pressure | Day 1, 8 hours post-dose (end of infusion) | The change in baseline for vital signs was reported for each arm. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | 4 hours | Treated (per Protocol set) - All randomized participants who were given both study treatments and completed the study as per protocol. Participants are included in the treatment group they received in each period. | mL | MEAN |
| SECONDARY | FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo | Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours | All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments. | percent of filtered sodium | MEAN |
| SECONDARY | FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo | Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours | All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments. | percent of filtered potassium | MEAN |
| SECONDARY | Furosemide Urinary Concentrations | Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours | All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments. | mg | MEAN |
| SECONDARY | Furosemide Plasma Concentrations | Day 1: 4, 5, 6, 8, 10 hours | All randomized subjects who started study drug infusion in at least one treatment period. This is also known as the Intent to Treat (ITT) population. Data in this data set was analyzed based on randomized sequence of treatments. | ng/mL | MEAN |
| SECONDARY | Ratio Urinary Sodium (Na) to Urinary Furosemide at 8 Hours Post-start Infusion | 0-4 hours after furosemide | Treated (per Protocol set) - All randomized participants who were given both study treatments and completed the study as per protocol. Participants are included in the treatment group they received in each period. | Ratio of Urinary Na:Urinary furosemide | MEAN |
| SECONDARY | Number of Participants With Clinically Relevant Hypotension | up to 8 hours | Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period. | Number of participants | NUMBER |
| SECONDARY | Number of Participants With an Adverse Event (AE) | up to 8 days | Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period. | Number of participants | NUMBER |
| SECONDARY | Number of Participants With an Abnormal Clinical Laboratory Value | from first dose to 30 days post-last dose (ca. 5-8 weeks) | Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period. | Number of participants | NUMBER |
| SECONDARY | Change From Baseline in Vital Signs - Blood Pressure | Day 1, 8 hours post-dose (end of infusion) | Safety set : All randomized participants who take at least 1 dose of double-blind study treatment. Participants were included in the treatment group they received in each period. | mmHg | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | BMS-986231 | Sequence 1 | 900.7 | Standard Deviation 366.56 | mL |
| 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | Placebo | Sequence 1 | 1603.3 | Standard Deviation 674.18 | mL |
| 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | BMS-986231 | Sequence 2 | 1176.7 | Standard Deviation 386.21 | mL |
| 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | Placebo | Sequence 2 | 1345.4 | Standard Deviation 391.11 | mL |
| 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | BMS-986231 | Total | 1032.1 | Standard Deviation 392.74 | mL |
| 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo | Placebo | Total | 1480.5 | Standard Deviation 559.92 | mL |
| FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo | BMS-986231 | Before start of infusion | 0.5 | Standard Deviation 0.52 | percent of filtered sodium |
| FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo | Placebo | Before start of infusion | 0.6 | Standard Deviation 0.73 | percent of filtered sodium |
| FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo | BMS-986231 | 0-4 hours | 0.6 | Standard Deviation 0.67 | percent of filtered sodium |
| FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo | Placebo | 0-4 hours | 0.7 | Standard Deviation 0.84 | percent of filtered sodium |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence 1 | 12 | |
| Overall Study | STARTED | Sequence 2 | 11 | |
| Overall Study | Period 1 Completion | Sequence 1 | 12 | |
| Overall Study | Period 1 Completion | Sequence 2 | 11 | |
| Overall Study | Period 2 Completion | Sequence 1 | 11 | |
| Overall Study | Period 2 Completion | Sequence 2 | 10 | |
| Overall Study | COMPLETED | Sequence 1 | 12 | |
| Overall Study | COMPLETED | Sequence 2 | 10 | |
| Overall Study | NOT COMPLETED | Sequence 1 | 0 | |
| Overall Study | NOT COMPLETED | Sequence 2 | 1 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lower respiratory tract infection | Infections and infestations | BMS-986231 | 0 | 23 | |
| other | Lower respiratory tract infection | Infections and infestations | Placebo | 2 | 23 | |
| other | Dizziness | Nervous system disorders | BMS-986231 | 2 | 23 | |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 23 | |
| other | Headache | Nervous system disorders | BMS-986231 | 3 | 23 | |
| other | Headache | Nervous system disorders | Placebo | 1 | 23 | |
| other | Hypotension | Vascular disorders | BMS-986231 | 3 | 23 | |
| other | Hypotension | Vascular disorders | Placebo | 0 | 23 | |
| serious | Myocardial infarction | Cardiac disorders | BMS-986231 | 1 | 23 | |
| serious | Myocardial infarction | Cardiac disorders | Placebo | 0 | 23 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS-986231 | 0 | 23 |
| Total, all-cause mortality | Placebo | 0 | 23 |
| Total, other adverse events | BMS-986231 | 6 | 23 |
| Total, other adverse events | Placebo | 3 | 23 |
| Total, serious adverse events | BMS-986231 | 1 | 23 |
| Total, serious adverse events | Placebo | 2 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31168885 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BMS-986231 vs Placebo: deaths from any cause | Trial comparisons |
| BMS-986231 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03730961
GET https://conductscience.org/api/trials/v1/NCT03730961/results?page=2