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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT00787059
Eligibility Criteria:
Inclusion Criteria
1. Male or non-pregnant female patients aged 18-80 years of age
2. ≥3-month history of heart failure
3. Compensated (stable) CHF not on intravenous inotropes, vasodilators or diuretics, on optimal medical and device therapy as defined by AHA/ACC Guidelines
4. LV ejection fraction (on optimal therapy) no greater than 40%
5. Implanted cardiac defibrillator
6. At least one major coronary artery (or graft) with \<50% proximal obstruction
7. Patients unable to walk (spinal injury, orthopedic problems) can be enrolled if all other criteria are met.
8. Women of child-bearing capacity must have a negative pregnancy test within 2 days of test substance administration, and female and male patients must be willing to use birth control during sex for 12w after test substance administration if the female partner is of child-bearing capacity.
9. Subjects willingly provide informed consent consistent with ICH-GCP guidelines
Exclusion Criteria
1. Unstable or Class IV angina
2. Coronary revascularization planned or predicted in next 6 months
3. Ischemic myocardium in 3 or more regions of a single perfusion bed, as assessed by stress echocardiography or jeopardized viable myocardium \>15% on perfusion imaging.
4. ≥50% occlusion of an "unprotected" left main coronary artery. If arterial or venous conduits provide blood flow to the distal left coronary circulation (ie, patent bypass grafts) then left main disease is "protected" and such patients are not excluded. The cardiologist performing the cardiac catheterization will make these decisions.
5. 2° AV Block (Mobitz 2) or 3° AV block unless pacemaker is present
6. Hospitalization for CHF requiring intravenous inotropes or vasodilators in the past 4 weeks
7. History of biopsy proven myocarditis
8. Myocardial infarction in previous 6 months
9. Restrictive, hypertrophic or infiltrative cardiomyopathy or chronic pericarditis
10. Previous or planned organ transplant recipient or donor.
11. Thrombocytopenia (\<100,000 platelets/µl) or bleeding diathesis
12. COPD requiring supplemental oxygen at home
13. AST \> 2 times upper limit of normal or chronic liver disease such as cirrhosis or Hepatitis C Virus (HCV). Patients with HCV are eligible only if both of two conditions are met: a) liver function tests are normal; AND b) liver biopsy is normal or shows only mild fibrosis.
14. Current or predicted hemodialysis within 12 months or estimated glomerular filtration rate (EGFR) \<30 ml/min. On online EGFR calculator that uses sex, age, body weight and serum creatinine is available at: www.kidney.org/professionals/kdoqi/gfr\_calculator.cfm. Use the higher of two EGFR results, which are based upon MDRD and CKD-EPI formulas.
15. CVA or TIA \<6 months prior to enrollment
16. Patients who are immunosuppressed by medicines (corticosteroids, methotrexate, cyclophosphamide, cyclosporine), illnesses (AIDS, HIV), or neutrophil count \<1000/mm3
17. Patients receiving other investigational drug therapy within 30 days of enrollment including gene transfer
18. Patients with diseases other than CHF that, in the opinion of the investigator, put the subject at risk or adversely affect the results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00787059
Study Brief:
Protocol Section:
NCT00787059