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

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ClinicalTrials.gov Identifier: NCT03357731
Recruitment Status : Recruiting
First Posted : November 30, 2017
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Cardiac Failure Reduced Ventricular Ejection Fraction Drug: HNO Donor Drug: Nitroglycerin (NTG) Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : May 29, 2019
Estimated Study Completion Date : May 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Placebo/BMS-986231/NTG
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
Drug: HNO Donor
Infusion
Other Name: BMS-986231

Drug: Nitroglycerin (NTG)
Infusion

Other: Placebo
Infusion

Experimental: Placebo/NTG/BMS-986231
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
Drug: HNO Donor
Infusion
Other Name: BMS-986231

Drug: Nitroglycerin (NTG)
Infusion

Other: Placebo
Infusion

Experimental: NTG/Placebo/BMS-986231
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
Drug: HNO Donor
Infusion
Other Name: BMS-986231

Drug: Nitroglycerin (NTG)
Infusion

Other: Placebo
Infusion

Experimental: NTG/BMS-986231/Placebo
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
Drug: HNO Donor
Infusion
Other Name: BMS-986231

Drug: Nitroglycerin (NTG)
Infusion

Other: Placebo
Infusion

Experimental: BMS-986231/Placebo/NTG
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
Drug: HNO Donor
Infusion
Other Name: BMS-986231

Drug: Nitroglycerin (NTG)
Infusion

Other: Placebo
Infusion

Experimental: BMS-986231/NTG/Placebo
administered in a cross over design with 5-hour infusions and 5-28 day wash-out periods
Drug: HNO Donor
Infusion
Other Name: BMS-986231

Drug: Nitroglycerin (NTG)
Infusion

Other: Placebo
Infusion




Primary Outcome Measures :
  1. Left Ventricle Stroke Volume Index (SVI) [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 5 hours ]
    computed by Simpson's method

  2. Mean Cardiac Power Index [ Time Frame: 5 hours ]
  3. The ratio of the time velocity integral of early-to-late ventricular filling (E/A) [ Time Frame: 5 hours ]
  4. Mean LV global longitudinal strain [ Time Frame: 5 hours ]
    computed using speckle-tracking echocardiography (STE)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357731


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
United States, California
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact: Joel Neutel, Site 0018         
United States, Illinois
Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Esther Vorovich, Site 0003    312-926-2671      
United States, Indiana
Local Institution Not yet recruiting
Indianapolis, Indiana, United States, 46202-1218
Contact: Site 0019         
United States, Massachusetts
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michael Givertz, Site 0005    617-732-7174      
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Ravi Karra, Site 0004    919-668-3282      
United States, Virginia
Inova Heart and Vascular Institute Recruiting
Falls Church, Virginia, United States, 22042
Contact: Lauren Cooper, Site 0007         
Japan
Local Institution Not yet recruiting
Nagoya-shi, Aichi, Japan, 4668560
Contact: Site 0009         
Local Institution Recruiting
Kawasaki-shi, Kanagawa, Japan, 2118533
Contact: Site 0011         
Local Institution Recruiting
Suita-shi, Osaka, Japan, 5650871
Contact: Site 0010         
Netherlands
Local Institution Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Site 0013         
United Kingdom
Local Institution Not yet recruiting
Clydebank, United Kingdom, G81 4DY
Contact: Site 0008         
Local Institution Active, not recruiting
Edinburgh, United Kingdom, EH16 4SA
Local Institution Recruiting
Glasgow, United Kingdom, G4 0SF
Contact: Site 0006         
Local Institution Recruiting
Glasgow, United Kingdom, G429LF
Contact: Site 0012         
Local Institution Recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Site 0002         
Local Institution Recruiting
Harrow, United Kingdom, HA1 3UJ
Contact: Site 0015         
Local Institution Recruiting
London, United Kingdom, SE1 1YR
Contact: Site 0001         
Local Institution Not yet recruiting
London, United Kingdom, sw17 0re
Contact: Site 0016         
Local Institution Recruiting
London, United Kingdom, SW3 6NP
Contact: Site 0017         
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03357731     History of Changes
Other Study ID Numbers: CV013-020
2016-003586-26 ( EudraCT Number )
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Nitroglycerin
Vasodilator Agents