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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03730961
Other study ID # CV013-034
Secondary ID 2018-000970-31
Status Completed
Phase Phase 2
First received
Last updated
Start date January 17, 2019
Est. completion date January 9, 2020

Study information

Verified date February 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in participants with heart failure and weakened heart function given a standard dose of diuretic.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date January 9, 2020
Est. primary completion date December 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Left ventricular ejection fraction <45%, as assessed by echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI) scan within 18 months - On stable chronic guideline-directed therapy for HF including chronic loop diuretics, ACEi, ARBs, MRAs, ARNI or / and ß-blockers as tolerated, with no changes of these medications in the past 2 weeks - At least an oral dose of 40 mg of furosemide/day or equivalent (20 mg torsemide, 1 mg bumetamide) Exclusion Criteria: - SBP < 115 mm Hg or > 180 mm Hg at screening or pre-randomization - Heart rate < 50 beats per minute (bpm) or > 120 bpm at screening or pre-randomization - Primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic or uncorrected severe valvular disease Other protocol defined inclusion/exclusion criteria could apply

Study Design


Intervention

Drug:
BMS-986231
Intravenous administration
Furosemide
Intravenous administration
Placebo
Intravenous administration

Locations

Country Name City State
United Kingdom Glasgow Clinical Research Facility Glasgow
United Kingdom Richmond Pharmacology London

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 4-hour Urinary Output Following Intravenous Administration of 40 mg Furosemide to HFrEF Participants Receiving BMS-986231 Infusion Compared to Placebo 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
4 hours
Secondary FeNa in Participants With HFrEF While on BMS-986231 Compared to Placebo 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
Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours
Secondary FeK in Participants With HFrEF While on BMS-986231 Compared to Placebo 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
Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours
Secondary Furosemide Urinary Concentrations Summary of urine recovery by interval, measured by amount excreted. Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours
Secondary Furosemide Plasma Concentrations Summary of plasma concentrations by interval. Day 1: 4, 5, 6, 8, 10 hours
Secondary Ratio Urinary Sodium (Na) to Urinary Furosemide at 8 Hours Post-start Infusion Summary of urinary concentrations 0-4 hours after furosemide
Ratio = Cumulative Sodium Excretion / Cumulative Furosemide in Urine
0-4 hours after furosemide
Secondary Number of Participants With Clinically Relevant Hypotension Clinically relevant hypotension is defined as systolic blood pressure (SBP) < 90 mmHg or symptomatic hypotension during infusion up to 8 hours
Secondary Number of Participants With an Adverse Event (AE) Clinically relevant hypotension is defined as systolic blood pressure (SBP) < 90 mmHg or symptomatic hypotension during infusion up to 8 days
Secondary Number of Participants With an Abnormal Clinical Laboratory Value Number of participants who experienced an in-study abnormal clinical laboratory event under the category of Hematology, Chemistry or Urinalysis. from first dose to 30 days post-last dose (ca. 5-8 weeks)
Secondary Change From Baseline in Vital Signs - Blood Pressure The change in baseline for vital signs was reported for each arm. Day 1, 8 hours post-dose (end of infusion)
Secondary Change From Baseline in Vital Signs - Heart Rate The change in baseline for vital signs was reported for each arm. Day 1, 8 hours post-dose (end of infusion)
Secondary Change From Baseline in Vital Signs - Oxygen Saturation The change in baseline for vital signs was reported for each arm. Day 1, 8 hours post-dose (end of infusion)
Secondary Change From Baseline in Electrocardiograms (ECGs) - Mean Heart Rate The change in baseline for ECGs was reported for each arm. Day 1, 8 hours post-dose (end of infusion)
Secondary Change From Baseline in Electrocardiograms (ECGs) - PR, QRS Duration, QT, QTcF Intervals The change in baseline for ECGs was reported for each arm. Day 1, 8 hours post-dose (end of infusion)
Secondary Telemetry Telemetry data not collected. Day 1, 8 hours post-dose
Secondary Change From Baseline in Physical Examination - Body Weight The change in baseline for physical examinations was reported for each arm. Day 1, 8 hours post-dose (end of infusion)
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