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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Heart Failure

Treatments: Drug: Placebo; Drug: HNO Donor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03016325

CV013-011

2016-001685-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 329 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II
• 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
• 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
• Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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329 participants in 5 patient groups, including a placebo group

Part 1 Cohort 1 HNO Donor

Experimental group

Treatment:

Drug: HNO Donor

Placebo Part 1 Cohort 1

Placebo Comparator group

Treatment:

Drug: Placebo

Part 2 Cohort 2 HNO Donor- low dose

Experimental group

Treatment:

Drug: HNO Donor

Part 2 Cohort 2 HNO Donor- high dose

Experimental group

Treatment:

Drug: HNO Donor

Placebo Part 2 Cohort 2

Placebo Comparator group

Treatment:

Drug: Placebo