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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03446651
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of decompensated heart failure with at least one objective sign of volume overload (rales, edema, elevated jugular venous pressure (JVP), or weight gain of at least 5 pounds)
* A projected need by the treating clinician for continued treatment with IV diuretics
* Chronic loop diuretic use
Exclusion Criteria:
* Inability to commit to or comply with serial visits for treatment in the Yale Transitional Care Center (YTCC)
* History of severe metabolic or respiratory acidosis within 30 days of enrollment
* Use of metformin, acetazolamide, or any other agent that could predispose to acidosis. Patients who are on metformin may be enrolled if their metformin can be discontinued safely for the duration of the study. Any participants who have consistently elevated Blood glucose readings \> 200 mg/dL while inpatient will not be enrolled.
* Serum bicarbonate level \<20mmol/L
* Estimated glomerular filtration rate \<20 mL/min or renal replacement therapy
* Appears unlikely, or unable to participate in the required study procedures, as assessed by the study PI or research registered nurse (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:
NCT03446651
Study Brief:
Protocol Section:
NCT03446651