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

Bristol-Myers Squibb23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cardiac Failure Myocardial Failure Congestive Heart Failure Heart Decompensation

Interventions

BMS-986231DRUG

Intravenous administration

FurosemideDRUG

Intravenous administration

PlaceboDRUG

Intravenous administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 β-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

Locations (2)

Glasgow Clinical Research Facility

Glasgow, United Kingdom

Richmond Pharmacology

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 4 hours

Secondary Outcomes

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

Time frame: Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours

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

Time frame: Day 1, predose; 0-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours

Furosemide Urinary Concentrations

Summary of urine recovery by interval, measured by amount excreted.

Time frame: Day 1, predose, 0-2 hours, 2-4 hours, 4-5 hours, 5-6 hours, 6-7 hours, 7-8 hours, 8-10 hours

Data from ClinicalTrials.gov

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