Phase
Condition
Hyponatremia
Chest Pain
Congestive Heart Failure
Treatment
N/AClinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 and < 80 years.
Systolic dysfunction with LVEF ≤ 35% as assessed by echocardiography.
Ischemic heart failure ineligible for further revascularization. Ischemic heartfailure is defined as history of myocardial infarction or evidence of clinicallysignificant coronary disease associated with LV systolic dysfunction leading to HF.The patient must not be a candidate for revascularization in the judgment of theinvestigator, based on the absence of unstable coronary-related symptoms and eithernon-invasive testing or coronary angiography within 24 months prior to screening.
Total MLHFQ score > 30.
Ability to perform a Six-Minute Walk Test > 100 m and ≤ 375 m.
History of hospitalization for HF within 12 months prior to screening or treatment inan out-patient clinic with intravenous therapy (including vasodilators, positiveinotropic agents, vasopressors or diuretics) for worsening HF within 12 months priorto screening. Be or must have been diagnosed within the previous 12 months in NYHAclass III or IV or INTERMACS class 4, 5, 6 or 7, and at the time of inclusion, must beat least in NYHA class II or greater. If in NYHA class II, 2 or more HF worseningevents or NT-ProBNP > 1000 pg/mL requiring hospitalization or outpatient IV therapyduring the prior 12 months are required.
Use of ACE inhibitor and/or ARB or sacubitril/valsartan (Entresto™); and beta blocker,for at least 3 months prior to screening visit, unless intolerant or contraindicated.
Stable dosing of ACE inhibitor or ARB or sacubitril/valsartan (Entresto™) and betablocker, aldosterone blocker, and diuretics for at least one month prior to screeningvisit, defined as ≤50% change in total dose of each agent.
Willing and able to give written informed consent.
Exclusion
Exclusion Criteria:
Women who are pregnant, confirmed by a positive urine or serum hCG laboratory test atscreening.
Women of child-bearing potential without a negative serum or urine pregnancy test atscreening or who are not practicing a reliable form of birth control. Women who arepostmenopausal (12 months of spontaneous amenorrhea or 6 months of spontaneousamenorrhea with serum FSH level > 40 mIU/mL or 6 weeks post-surgical bilateraloophorectomy) or surgically sterile are not considered to be of child-bearingpotential. Reliable contraception includes surgical sterilization, hormonalcontraception, or double-barrier methods.
Men refusing to exercise a reliable form of contraception unless partner is unable toconceive.
Acute coronary syndrome leading to myocardial infarction or unstable angina within 90days of screening.
Percutaneous coronary intervention (PCI) within 90 days prior to screening, or CABGsurgery within 180 days prior to screening.
Patient on a cardiac transplant list or previously received any solid organtransplant.
Previously underwent cardiac surgery with remodeling procedure, left ventricularassist device placement or cardiomyoplasty. This exclusion does not apply to patientswho underwent ventricularplasty without placements device >1 year ago.
Patient has undergone cardiac resynchronization therapy (CRT) within 6 months (180days) prior to screening.
Severe uncontrolled HF requiring need for intravenous diuretics or inotropic supportwithin 1 month prior to screening.
Inability to perform a Six-Minute Walk Test due to physical limitations other than HFincluding:
Severe peripheral vascular disease
Severe pulmonary disease or chronic obstructive pulmonary disease (COPD) withFEV1 <30% predicted
Orthopedic limitations, severe muscular diseases, any other joint or musculardisease or neurological disorder (such as an old stroke or neuropathy) limitingthe ability to walk for 6 minutes.
Dependence on chronic oral steroid therapy.
Stroke or transient ischemic attack leading to limitations in lower extremities oroccurring within 180 days prior to screening.
Active myocarditis, constrictive pericarditis, restrictive, hypertrophic or congenitalcardiomyopathy.
BMI < 19 or > 40 kg/m2.
Left ventricular thrombus.
Left ventricular wall thickness < 8mm visualized in more than 50% of LV, and definedas a "LV no-go zone
LV aneurysm or candidate for surgical aneurysmectomy.
Sustained VT or VF which led to AICD therapy (shock) within 3 months prior toscreening.
Primary valvular disease of ≥ moderate degree, including mitral or aortic stenosis (with aortic valve area < 1.5 cm2) or regurgitation. Secondary mitral and tricuspidregurgitation due to LV dilatation will not be excluded
Prosthetic valve in aortic or mitral position, or prior MitraClip placement.
Chronic infection or active malignancy.
Compromised renal function as reflected by a serum creatinine level >2,0 mg/dL (>0.177mmol/l) or is currently on dialysis.
Hematocrit < 28%.
Atherosclerosis and/or tortuosity of the aorta, iliac or femoral arteries of a degreethat could impede or preclude the safe retrograde passage of the delivery catheter,including untreated aneurysm of the aorta.
Chronic immunosuppressive therapy due to inflammatory or systemic disease.
Patient tested positive for HIV 1 or 2, Hepatitis B or C, HTLV 1 or syphilis (asdetailed in Section 19.1).
Exposure to any previous experimental cell or angiogenic therapy and/or myocardiallaser therapy and/or therapy with another investigational drug within 60 days prior toscreening or enrollment in any concurrent study that may confound the results of thisstudy.
Known drug or alcohol dependence or any other factors which will interfere with thestudy conduct or interpretation of the results or in the opinion of the investigatorare not suitable to participate.
Any illness other than CHF which might reduce life expectancy to less than 2 yearsfrom screening.
Known and relevant allergies and/or hyper-sensitivities to Dextran or other plasmavolume expanders (including Gentran, Hyskon and Macrodex), to Bovine Serum Albumin (BSA) or to any albumin from animal origin.
Known severe allergy to the cardiac radiological contrast mixture.
Required dosage of cardiopoietic cells not reached