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



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:November 30, 2017
End Date:May 29, 2019

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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Cross-over Phase 2 Study of Continuous 5-Hour Intravenous Infusions of BMS-986231 in Patients With Heart Failure and Impaired Systolic Function

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.


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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
We found this trial at
7
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-7174
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Chicago, Illinois 60611
Phone: 312-926-2671
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Durham, North Carolina 27710
Phone: 919-668-3282
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Falls Church, Virginia 22042
Phone: 703-776-3697
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340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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Nagoya-shi, Aichi 46685
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Tustin, California
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Tustin, CA
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