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Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure (STANDUP AHF)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03016325
First received: January 9, 2017
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function

Condition Intervention Phase
Heart Failure
Drug: HNO Donor
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Dose-Ranging, Phase 2b Study of the Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of BMS-986231 in Hospitalized Patients With Heart Failure and Impaired Systolic Function

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Clinically relevant hypotension [ Time Frame: Hour 0 to 6 hours after the end of study drug infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in NT-proBNP (N-terminal prohormone of brain natriuretic peptide) [ Time Frame: From baseline to hour 24, 48, 72, 120 or discharge (whichever comes first), and at day 32 ] [ Designated as safety issue: No ]
  • Change in patient-reported resting dyspnea, as measured by the area under the curve (AUC) of the 11-point Numerical Rating Scale (NRS) [ Time Frame: From baseline to hour 6, 12, 24, 48 and 72 ] [ Designated as safety issue: No ]

Estimated Enrollment: 310
Study Start Date: January 2017
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Cohort 1 HNO Donor Drug: HNO Donor
Infusion
Other Name: BMS-986231
Placebo Comparator: Placebo Part 1 Cohort 1 Drug: Placebo
Infusion
Experimental: Part 2 Cohort 2 HNO Donor- low dose Drug: HNO Donor
Infusion
Other Name: BMS-986231
Experimental: Part 2 Cohort 2 HNO Donor- high dose Drug: HNO Donor
Infusion
Other Name: BMS-986231
Placebo Comparator: Placebo Part 2 Cohort 2 Drug: Placebo
Infusion

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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:

  • Actively being hospitalized for acute decompensated heart failure
  • At least 1 administration of IV diuretic for the current episode
  • Be randomized within 18 hours of first dose of IV diuretic for current episode
  • Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic
  • Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%

Exclusion Criteria:

  • Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm
  • Have an active infection requiring IV anti-microbial treatment
  • Severe lung disease that may interfere with assessments (e.g., severe chronic obstructive pulmonary disease, active asthma or acute pneumonia)
  • Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening
  • Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening

Other protocol defined inclusion/exclusion criteria could apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03016325

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 #.

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03016325     History of Changes
Other Study ID Numbers: CV013-011  2016-001685-29 
Study First Received: January 9, 2017
Last Updated: January 9, 2017
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2017