Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT01982292
Eligibility Criteria:
Key Inclusion Criteria:
* Body weight of ≤ 160 kg.
* Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior documented history of chronic heart failure.
* NT-proBNP \>300 pg/ml (according to central measurement) at visit 1.
* Subjects treated with appropriate and guideline-indicated CHF standard of care.
* Ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.
Key Exclusion Criteria:
* Current acute decompensated HF
* Any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
* Documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without ICD (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
* Presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
* Subjects with severe renal impairment defined as pre-randomization eGFR \< 30 ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or planned dialysis or ultrafiltration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01982292
Study Brief:
Protocol Section:
NCT01982292