Efficacy, Safety and Tolerability of Sexelaxin When Added to Standard Therapy in AHF
- Conditions
- Acute Heart Failure
- Registration Number
- JPRN-jRCT2080222681
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 300
Male or female>= 18 years of age, with body weight <= 160 kg
-Hospitalized for AHF; AHF is defined as including all of the following measured at any time between presentation (including the emergency department and outpatient clinic) and the end of screening:
-Dyspnea at rest or with minimal exertion
-Pulmonary congestion on chest radiograph
-Brain natriuretic peptide (BNP) >= 350 pg/mL or NT-proBNP >= 1,400 pg/mL
-Systolic BP >= 125 mmHg at the start and at the end of screening
-Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
-Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode
-Renal impairment defined as an estimate glomerular filtration rate using the between presentation and randomization of >= 25 and <= 75mL/min/1.73m2, calculated using the Modification of Diet in Renal Disease formula(or modified sMDRD formula according to specific ethnic groups and local practice guidelines).
-Dyspnea primarily due to non-cardiac causes
-Temperature more than 38.5C (oral or equivalent), sepsis, active and clinically significant infection requiring IV anti-microbial treatment or known presence or evidence of Human Immunodeficiency Virus (HIV) infection (based on history and/or clinical findings, including laboratory results obtained during screening period).
-Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment
-AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate less than 45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of more than 130 beats per minute
-Hepatic disease unrelated to Heart Failure etiology and as determined by any one of the following: AST and/or ALT values exceeding 3 X ULN and/or bilirubin more than 1.5 X ULN at screening or history of hepatic encephalopathy, esophageal varices, or portacaval shunt, or a diagnosis of cirrhosis by any means, or evidence of chronic Hepatitis B (presence of hepatitis B surface antigen production: positive HBsAg), or chronic Hepatitis C infection (presence of Hepatitis C genetic replication: positive Hepatitis C viral RNA, based on history and/or clinical findings, including laboratory results obtained during screening period).
*Significant uncorrected left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area less than 1.0 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis
-History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 1 year
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method