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 @ 12:15 PM
Ignite Modification Date:
2025-12-24 @ 12:15 PM
NCT ID:
NCT06545461
Eligibility Criteria:
Inclusion Criteria:
1. Non-malignant high blood pressure or hypertension
2. 18-70 yrs old
3. urine albumin-to-creatine ratio \> 200 mg/g creatinine
4. estimated glomerular filtration rate (eGFR) 30 to 59 ml/min/1.73 m2
5. Plasma total CO2 (PTCO2) \> 22 but \< 24 mmol/l
6. able to tolerate angiotensin converting enzyme \[ACE\] inhibition drug therapy because guidelines recommend it for patients with albuminuric CKD
7. non-smoking
8. greater than or equal to 2 primary care visits in the preceding year, indicating compliance
9. Able to provide informed consent.
Exclusion Criteria:
1. Malignant hypertension or history thereof
2. primary kidney disease or findings consistent thereof such as \> 3 red blood cells per high powered field of urine or urine cellular casts
3. history of diabetes or fasting glucose greater than or equal to 110/mg/dl
4. history of hematologic disorders, malignancies, chronic infections, current pregnancy, history or clinical evidence of CVD
5. peripheral edema or diagnosis associated with edema such as heart/liver failure or nephrotic syndrome because of the sodium load that accompanies NaHCO3 therapy
6. baseline plasma potassium concentration \> 4.6 mmol/l to reduce the risk for hyperkalemia in those participants randomized to F+Vs which increases dietary potassium intake
7. taking, or unable to stop taking, drugs other than ACE inhibitors that limit urine potassium excretion
8. Unable to provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06545461
Study Brief:
Protocol Section:
NCT06545461