Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Capricor Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to provide written informed consent after reviewing the design and risks of the study and prior to completing any study-related procedure
Willing and able to understand and comply with all study procedures and requirements, including in-patient stay
Current or historical New York Heart Association (NYHA) functional class ≥ II
Glomerular Filtration Rate (GFR) ≥ 30 and ≤ 60 mL/min at the time of screening
Systolic blood pressure 120-160 mmHg at the time of screening
Stable and compliant treatment with oral medications for at least 4 weeks prior to screening
Body Mass Index (BMI) ≥18 and ≤45 kg/m2 at the time of screening
Women of child bearing potential (WOCBP) and males must agree to use at least two forms of contraception, of which one includes a barrier method (male condom) by the male partner, during study participation and continued for at least 90 days after the conclusion of the final infusion rate. In addition, sperm donations by male subjects are not permitted during the subject's participation in the research study and for at least 90 days after the conclusion of the final infusion rate. This criterion may be waived for male subjects who have undergone a vasectomy at least 6 months prior to screening
Willing and able to abstain from drugs, alcohol, and tobacco during study participation
You may not be if
Hypersensitivity or allergy to natriuretic peptides
Acute decompensated heart failure (ADHF) within 30 days prior to randomization
Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to randomization
Symptomatic postural hypotension
Concomitant medication of an aldosterone blocker (e.g., eplerenone or spironolactone) within 30 days prior to randomization
Potassium of ≥ 5.0 mmol/L
Evidence of uncorrected volume or sodium ≤ 130 mmol/L within 24 hours prior to randomization
Clinically significant aortic or mitral valve stenosis
Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
