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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03357731
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group 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
Anticipated Study Start Date : November 30, 2017
Estimated Primary Completion Date : December 4, 2018
Estimated Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: HNO Donor, NTG, Placebo
administered in a cross over design with 5-hour infusions and 7-28 day wash-out periods
Drug: HNO Donor
Infusion
Other Name: BMS-986231
Drug: Nitroglycerin (NTG)
Infusion
Other: Placebo
Infusion


Outcome Measures

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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 ≥ 300 pg/mL (35 pmol/L) or BNP ≥ 100 pg/mL (29 pmol/L)

Exclusion Criteria:

  • Systolic blood pressure (SBP) < 115 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
  • Paced rhythm (VVI, DDD or BiV pacing)

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

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, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Site 0003         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Site 0005         
United States, North Carolina
Local Institution Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Site 0004         
United States, Virginia
Local Institution Not yet recruiting
Falls Church, Virginia, United States, 22042
Contact: Site 0007         
Japan
Local Institution Not yet recruiting
Nagoya, Aichi, Japan, 4668560
Contact: Site 0009         
Local Institution Not yet recruiting
Kawasaki-shi, Kanagawa, Japan, 2118533
Contact: Site 0011         
Local Institution Not yet recruiting
Suita, Osaka, Japan, 5650871
Contact: Site 0010         
United Kingdom
Local Institution Not yet recruiting
Clydebank, United Kingdom, G81 4DY
Contact: Site 0008         
Local Institution Not yet recruiting
Glasgow, United Kingdom, G4 0SF
Contact: Site 0006         
Local Institution Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Site 0002         
Local Institution Not yet recruiting
London, United Kingdom, SW17 0RE
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
More Information

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: November 30, 2017
Last Verified: November 2017

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