A Study of Continuous Infusions of HNO (Nitroxyl) Donor in Patients With Heart Failure and Impaired Systolic Function

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Cardiac Failure, Reduced Ventricular Ejection Fraction

In brief

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.

Key facts

Study ID

NCT03357731

Run by

Bristol-Myers Squibb

People needed

49

Starts

2017-11-30

Expected to finish

2019-05-10

Last updated by the study team

2020-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heart failure with reduced ejection fraction (LVEF on echocardiogram of 40% or less)
• Stable guideline directed therapy for heart failure including oral diuretics, ACEi, ARBs, ARNi, MRAs, and β blockers as tolerated, with no dose changes of these medications in the past 2 weeks
• Have screening values of NT pro-BNP ≥ 125 pg/mL (15 pmol/L) or BNP ≥ 35 pg/mL (10 pmol/L)

You may not qualify if…

• Systolic blood pressure (SBP) < 110 mm Hg at screening or pre-randomization
• Heart rate < 50 beats per minute (bpm) or > 90 bpm at screening or pre-randomization
• Permanent Atrial Fibrillation, Atrial Flutter or having Atrial Fibrillation, Atrial Flutter
• Estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73 m2
• Ventricular assist device or prior heart transplant
• Prior solid organ transplant
• Body weight < 45 kg or ≥ 140 kg
• Low quality echocardiographic visualization windows and image acquisition
• Permanent paced rhythm (VVI, DDD or BiV pacing)
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Orange County Research Center — Tustin, California, United States
• Northwestern Medicine — Chicago, Illinois, United States
• Indiana University School of Medicine-Indianapolis — Indianapolis, Indiana, United States
• Brigham and Womens Hospital — Boston, Massachusetts, United States
• Duke Advanced Heart and Lung Failure Clinic — Durham, North Carolina, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States
• Local Institution — Nagoya, Aichi-ken, Japan
• Local Institution — Kawasaki, Kanagawa, Japan
• Local Institution — Suita-shi, Osaka, Japan
• Local Institution — Groiningen, Netherlands
• Local Institution — Edinburgh, United Kingdom
• Local Institution — Glasgow, United Kingdom
• Local Institution — Glasgow, United Kingdom
• Local Institution — Glasgow, United Kingdom
• Local Institution — Harrow, United Kingdom
• Local Institution — London, United Kingdom
• Local Institution — London, United Kingdom
• Local Institution — London, United Kingdom

Full record on ClinicalTrials.gov

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