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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT05189418
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged ≥18 years.
2. Wrist circumference between 13.5 and 21.5 cm to enable proper use of the NightView HBPM device (only for those who might use it).
3. Upon recruitment have moderate to severely decreased eGFR, i.e., stages G3b (eGFR 30-44 ml/min/1.73 m2) or G4 (eGFR 15-29 ml/min/1.73 m2).
4. Agreement to adhere lifestyle considerations (routine of daytime activity and nighttime sleep) and mandates (e.g., wearing of NightView and ABPM devices) of the investigative protocol.
5. Provision of written informed consent to participate into the study.
Exclusion Criteria:
1. Pregnancy.
2. History of alcoholism or narcotic addiction within the last two years.
3. Night, rotating shift-work employment, or frequent transmeridian travel.
4. Previous history of a systemic autoimmune disease or AIDS.
5. Evidence of a secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma.
6. Severe cardiac disease (unstable angina pectoris, unstable heart failure, life-threatening arrhythmia, and atrial fibrillation). Previous CVD events will not be exclusionary if full physical and work activities are maintained.
7. Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any medication, or, at the discretion of the investigator, might place the subject at higher medical risk from his/her participation in the study, or is likely to prevent the subject from complying with the requirements of the study or completing the trial period.
8. History of any malignancy within the past five years, including leukemia and lymphoma (but not basal cell skin cancer), or any other severe disease if involving life-threatening risk.
9. Inability to communicate and comply with all study requirements.
10. Intolerance to or unacceptance of ABPM or HBPM.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05189418
Study Brief:
Protocol Section:
NCT05189418