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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT02737995
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to provide written informed consent
* Age 21-80 years
* Chronic heart failure \>3 months with NYHA Class I-III symptoms
Exclusion Criteria:
* Presence of implantable defibrillator, permanent pacemaker not designed for safe use in 3T MRI stud
* Metallic implant or implants that are deemed not suitable for MRI scan on 3T
* Aneurysm clips, cochlear implants, presence of shrapnel in strategic locations, and metal in the eye
* Known claustrophobia or any other history of intolerance of MRI procedure
* Treated diabetes mellitus or hemoglobin A1c (HbA1c) \>6.5%
* Any hospitalization \<60 days
* Myocardial infarction or stroke \< 6 months
* Estimated glomerular filtration rate \<30 ml/min
* Weight \<50 or \>120 kg
* Systolic blood pressure \<90 mmHg or \> 160 mmHg
* Heart rate \<50 or \>100 beats per minute
* Resting oxygen saturation on room air \<92%
* Hemoglobin \<11 g/dl
* Serum phosphate below normal range (\<2.4 mg/dl)
* Liver function tests (AST, ALT, Alk Phos, or Total Bilirubin) \>twice upper limit of normal range
* Pregnancy or current breastfeeding
* Exercise limitation primarily due to valvular heart disease, lung disease, neuromuscular disease, or joint disease
* History of asthma
* History of anaphylaxis
* Known history of intolerance to any formulation of intravenous iron
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT02737995
Study Brief:
Protocol Section:
NCT02737995