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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01855334
Eligibility Criteria:
Inclusion Criteria:
* Chronic dialysis therapy for End Stage Renal Disease
* Age 21-85
Exclusion Criteria:
* Hyperkalemia requiring unscheduled dialysis within 3 months
* Pre-dialysis potassium ≥6.5 meq/L within 3 months
* Hypotension defined as SBP \<100
* Recurrent intra-dialytic hypotension defined as recurrent cramping, light-headedness, or hypotension requiring infusion of saline or other intervention or otherwise limiting ability to achieve dry weight. Or SBP \<80
* History of myocardial infarction
* History of coronary artery bypass surgery
* Non revascularized coronary disease \>90%
* Mitral valve repair or replacement
* Severe mitral valve disease
* Renal transplant expected within 9 months
* Expected survival \< 9 months
* Pregnant
* Prisoners
* Unable to provide consent
* Allergy to spironolactone or L-arginine
* Digitalis use
* 1st or 2nd degree heart block
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01855334
Study Brief:
Protocol Section:
NCT01855334