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
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
1 Location
Brief description of study
Acute Decompensated Heart Failure (ADHF) is when the signs and symptoms of heart failure get worse. These symptoms can include difficulty breathing (dyspnea), leg or foot swelling, and fatigue. ADHF is a common and potentially serious cause of troubled breathing. It is caused by your heart not pumping as strong as it should.
The purpose of this study is to evaluate the safety, and effectiveness of BMS-986231 BMS-986231in patients with acute heart failure when added to the standard treatment.
Detailed description of study
The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986231 in subjects with heart failure (HF)and reduced systolic function who are admitted to the hospital with signs and symptoms of acute decompensated heart failure.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: heart failure
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria
hospitalized for acute decompensated hearth failure (ADHF)
Exclusion Criteria
Considered clinically unstable for other conditions than acute heart failure, either because of acute coronary syndrome or ongoing arrhythmia (or be receiving concomitant parenteral therapy with any antiarrhythmic drugs), or other unstable non-cardiovascular disease
Severe chronic or acute lung disease that might interfere with the ability to interpret the dyspnea assessments (eg, severe chronic obstructive pulmonary disease, active asthma or acute pneumonia)
Have a history of sudden cardiac death with resuscitation within the past 6 months
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
Severe liver disease defined as history of cirrhosis with evidence of portal hypertension such as varices, or encephalopathy
Prior cardiac or renal transplant
hospitalized for acute decompensated hearth failure (ADHF)
Exclusion Criteria
Considered clinically unstable for other conditions than acute heart failure, either because of acute coronary syndrome or ongoing arrhythmia (or be receiving concomitant parenteral therapy with any antiarrhythmic drugs), or other unstable non-cardiovascular disease
Severe chronic or acute lung disease that might interfere with the ability to interpret the dyspnea assessments (eg, severe chronic obstructive pulmonary disease, active asthma or acute pneumonia)
Have a history of sudden cardiac death with resuscitation within the past 6 months
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
Severe liver disease defined as history of cirrhosis with evidence of portal hypertension such as varices, or encephalopathy
Prior cardiac or renal transplant
Updated on
04 Aug 2024.
Study ID: 1611169140
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Interested in the study?
This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.
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