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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT03027960
Eligibility Criteria:
Inclusion Criteria:
* Stable HF as defined by:
* No hospitalization for \>60 days
* Stable HF medications for \>=2 weeks, and stable diuretics for 4 weeks
* Opinion of HF cardiologist that the patient is at their optimal volume status
* Chronic daily oral loop diuretic dose \>=20mg furosemide equivalents
* Diagnosis of type II diabetes
* Patient monitors blood glucose regularly at home
* eGFR \>=45 mL/min/1.73 m2
* \>=18 years old
Exclusion Criteria:
* Active titration of chronic HF medications expected during the study period
* Use of a non-loop diuretic, aside from an aldosterone antagonist (\<=25mg spironolactone or \<=50mg eplerenone)
* Critical stenotic valvular disease, complex congenital heart disease, or prior heart transplant
* History of diabetic ketoacidosis, "brittle" diabetes, and/or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (ER visit or EMS response, glucagon administration or forced oral carbs) in the last 6 months
* History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections
* Anemia (defined as hemoglobin \<8g/dL)
* Pregnancy or breastfeeding
* History of serious hypersensitivity
* Participation in another trial with an investigational drug within the 30 days prior to informed consent
* Use of another SGLT-2 inhibitor
* Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research RN (ex: clinically-significant psychiatric, addictive, or neurological disease)
* Inability to give written informed consent or follow study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03027960
Study Brief:
Protocol Section:
NCT03027960