ARIISE - ASCs in recently diagnosed non-ischemic heart failure

Other illness

• NYHA I or IV heart failure
• Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) < 1 L/min or body mass index > 35kg/m^2
• History with malignant disease within five years of inclusion or current suspected malignancy – except treated skin cancer other than melanoma
• Patients with known hypersensitivity to DMSO and Dextran-40
• Documented ischemic heart failure
• Acute coronary syndrome with elevation of CKMB (Creatine Phosphatase-Myocardial Band) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
• Expected to undergo screening for heart transplantation during the study time
• Listed for heart transplantation
• Other cardiac revascularization treatments to be performed
• Moderate to severe aortic stenosis (valve area < 1.1 cm2) or clinically significant mitral valve disease

Lab values

• Clinically significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2x10^9/L), leucocytosis (leucocytes >14x10^9/L) or thrombocytopenia (thrombocytes < 50x10^9/L)

Other

• Pregnant women
• Ongoing alcohol abuse
• Implantation of CRT within 3 months or ICD within 1 month

• > 18 years of age
• Diagnosed with non-ischemic heart failure with initial LVEF (left ventricular ejection fraction) ≤ 40% and then up-titrated to maximal tolerable heart failure medication within the last 12 months
• Symptomatic heart failure (NYHA II-III)
• LVEF ≤ 45% documented by echocardiography, CT or MRI performed after up-titration of heart failure medication (documentation of reduced LVEF at least after 1 and 3 months if implantation of a device either an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronisation Therapy (CRT), respectively)
• Plasma Pro-BNP > 300 pg/ml (> 35 pmol/L) in patients with sinus rhyth and plasma Pro BNP > 422 pg/ml (> 49 pmol/L) in patients with atrial fibrillation