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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT05732727
Eligibility Criteria:
Inclusion Criteria:
* Male or female \>=18 years with a clinical frailty score ≤5 for patient aged over 80
* Advanced or moderate chronic kidney disease (eGFR 15 to 44.9 mL/min/1.73m² using CKD-EPI formula)
* Arterial hypertension treated with at least one blood pressure lowering drug therapy among blockers of the renin-angiotensin system (ACEi or ARB), at the maximal posology tolerated by the patients stable since at least one month. Other blood pressure lowering drug therapies are tolerated in combination with or in the event of intolerance to ACE inhibitors or ARBs.
* Uncontrolled office BP
* Uncontrolled office BP (\>140 and/or 90 mmHg) confirmed by home blood pressure monitoring (\>135 and/or 85 mmHg) or Day-time Ambulatory Blood Pressure Monitoring
* Participant covered by or entitled to social security
* Written informed consent obtained from the participant
Exclusion Criteria:
* Patient following any measures of legal presentation
* Pregnant or breastfeeding woman
* woman of childbearing without a highly effective contraceptive measure (combined or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device or intrauterine hormone-releasing system)
* Clinical signs of hypovolemia
* Symptomatic orthostatic hypotension
* Hyponatremia (\<130 mmol/L)
* Dyskalemia (\<3,5 mmol/L or \>5,5 mmol/L)
* Major adverse cardiovascular event during the last three months: myocardial infarction, heart failure hospitalization, stroke
* Current medical history of cancer requiring chemotherapy
* Solid organ transplantation
* Two or more diuretic agents (loop diuretic, thiazides and thiazide-like diuretics)
* Mineralocorticoid receptor antagonists
* Autosomal dominant polycystic kidney disease treated with Tolvaptan
* Contraindication to diuretics involved in the algorithm
* Severe heart failure (NYHA III\_IV)
* Cirrhosis Child B-C
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05732727
Study Brief:
Protocol Section:
NCT05732727