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:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT02941705
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 50 years old, male or female
2. LVEF ≥ 50%
3. Symptoms and physical findings of chronic heart failure (NYHA class II- ambulatory IV)
4. Treatment with a stable, maximally-tolerated dose of diuretic(s) for a minimum of 30 days prior to randomization.
5. Left atrial (LA) enlargement defined by at least one of the following: LA width (diameter) ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20 cm2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m2
6. BNP \> 125 pg/ml for patients in NSR or \> 150 pg/ml for patients in AF (BNP are BMI corrected) or resting PCWP \> 15 mmHg, or exercise PCWP \> 18 mmHg
Exclusion criteria-Specific to HFpEF
1. Any prior echocardiographic measurement of LVEF \< 40 %
2. Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to randomization
3. Unrevascularized, hemodynamically significant CAD (FFR \< 0.75)
4. Current acute decompensated HF
5. Alternative diagnoses that in the opinion of the investigator could account for the patient's HF symptoms (i.e., dyspnea, fatigue) such as severe pulmonary disease (i.e., requiring home oxygen, chronic nebulizer therapy, chronic oral steroid therapy); hemoglobin (Hgb) \< 10 g/dl; body mass index (BMI) \> 40 kg/m2
6. Use of investigational drugs or treatments at the time of enrollment
7. Systolic blood pressure \> 150 mmHg but \< 180 mmHg unless receiving 3 or more antihypertensive drugs
8. History of any dilated cardiomyopathy; right sided HF in the absence of left-sided structural heart disease; Pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy; clinically significant congenital heart disease; hemodynamically significant valvular heart disease
9. Stroke, transient ischemic attack, carotid surgery or carotid angioplasty within the 3 months
10. Uncontrolled dysrhythmia; symptomatic or sustained ventricular tachycardia or atrial fibrillation or flutter with a resting ventricular rate \> 110 beats per minute (bpm)
11. Prior major organ transplant or intent to transplant (i.e., on transplant list)
12. Hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x the upper limit of normal (ULN), bilirubin \> 1.5 mg/dl; history of chronic viral hepatitis
13. Chronic Kidney Disease with eGFR \< 30 mL/min/1.73 m2; serum potassium \> 5.5 mmol/L (mEq/L)
14. History or presence of any other disease with a life expectancy of \< 3 years
15. Non-compliance to medical regimens
16. Drug or alcohol abuse within the last 12 months
17. History of malignancy within the past 5 years
18. Pregnant or nursing (lactating) women confirmed by a positive human chorionic gonadotropin (hCG); women of child-bearing potential (physiologically capable of becoming pregnant), unless using highly effective contraception methods during study
Exclusion criteria-Specific to CAP-1002 (not listed above)
1. Diagnosis of active myocarditis
2. Known hypersensitivity to contrast agents or previous H/O HIT
3. Known hypersensitivity to dimethyl sulfoxide (DMSO)
4. Known hypersensitivity to bovine products
5. Active infection not responsive to treatment
6. Active allergic reactions, connective tissue diseases or autoimmune disorders
7. History of cardiac tumor or cardiac tumor demonstrated on screening
8. History of previous stem cell therapy
9. History of treatment with immunosuppressive agents, including chronic systemic corticosteroids, biologic agents targeting the immune system, anti-tumor and anti-neoplastic drugs or anti-VEGF within 6 months prior to enrollment (not including drug-eluting coronary stents)
10. Human Immunodeficiency Virus (HIV) infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02941705
Study Brief:
Protocol Section:
NCT02941705