Trial · NCT03730961
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Secondary | Change From Baseline in Vital Signs - Heart Rate | Day 1, 8 hours post-dose (end of infusion) | The change in baseline for vital signs was reported for each arm. |
| Secondary | Change From Baseline in Vital Signs - Oxygen Saturation | Day 1, 8 hours post-dose (end of infusion) | The change in baseline for vital signs was reported for each arm. |
| Secondary | Change From Baseline in Electrocardiograms (ECGs) - Mean Heart Rate | Day 1, 8 hours post-dose (end of infusion) | The change in baseline for ECGs was reported for each arm. |
| Secondary | Change From Baseline in Electrocardiograms (ECGs) - PR, QRS Duration, QT, QTcF Intervals | Day 1, 8 hours post-dose (end of infusion) | The change in baseline for ECGs was reported for each arm. |
| Secondary | Telemetry | Day 1, 8 hours post-dose | Telemetry data not collected. |
| Secondary | Change From Baseline in Physical Examination - Body Weight | Day 1, 8 hours post-dose (end of infusion) | The change in baseline for physical examinations was reported for each arm. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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