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 @ 4:51 PM
Ignite Modification Date:
2025-12-24 @ 4:51 PM
NCT ID:
NCT05378750
Eligibility Criteria:
Inclusion Criteria:
* Adult (\>18 years old) outpatient with uncontrolled hypertension; defined as, AMBP ≥ 130/80 mmHg despite treatment
* With an estimated glomerular filtration rate (eGFR) of 15-45 ml/min/1.73 m2.
* Fluid overload of more than 5% of estimated normal ECFV, as assessed by Bio-impedance spectroscopy (we are using the Body Composition Monitor, a validated device marketed by Fresenius, Canada).
Exclusion Criteria:
* Pregnancy or lactation
* Declined informed consent
* Patients with cognitive dysfunction
* Surgery within six weeks of the study
* Patients with heart failure, atrial fibrillation, stroke, nephrotic syndrome and active auto-immune disease
* Patients with severe life-limiting comorbidities like cancer
* Patients with amputated limbs (despite the fact that the BCM device can be used if people have a unilateral amputation, the home devices measure via 2 legs).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05378750
Study Brief:
Protocol Section:
NCT05378750