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 @ 1:42 AM
Ignite Modification Date:
2025-12-25 @ 1:42 AM
NCT ID:
NCT06176794
Eligibility Criteria:
Inclusion Criteria:
* Man or woman over the age of 18 years.
* Willing and able to sign the informed consent.
* A clinical diagnosis of chronic HF that is considered by patient's cardiologist/physician to be stable over the one-month period prior to randomization.
* Receiving a stable dose of furosemide of 40mg or 80mg total per day (or equivalent doses of torsemide or bumetanide) for at least 30 days prior to randomization.
* Optimum volume status determined by experienced physician.
* Able to consume a diet containing approximately 3 grams of Na+ daily.
* No anticipated changes in HF medications during the study period.
Exclusion Criteria:
* Requirement for a diuretic other than furosemide, bumetanide or torsemide except for spironolactone, eplerenone, finerenone, or SGLT2 inhibitors, given in stable dose for \> 2 weeks before randomization and during the study.
* Known non-adherence to medication intake or salt restriction.
* Myocardial infarction, stroke, transient ischemic attack, acute kidney injury or acute HF requiring admission to hospital within the last 30 days prior to randomization.
* Severe / symptomatic lung disease or respiratory symptoms distinct from HF.
* Urinary incontinence or inability to empty bladder with a post-void residual volume \>100 ml.
* Uncontrolled diabetes mellitus or uncontrolled hypertension.
* Estimated GFR \< 30 ml/min/1.72m2 of body surface area.
* Use of any non-loop diuretic in the last 30 days prior to randomization, with the exception of a low dose MRA (e.g., spironolactone of 25-50 mg per day) or an SGLT2 inhibitor.
* History of flash pulmonary edema or amyloid cardiomyopathy.
* Requirement for a non-steroidal anti-inflammatory drug other than low dose aspirin (\<200 mg daily)
* Refusal or inability to sign the informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06176794
Study Brief:
Protocol Section:
NCT06176794