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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT06744335
Eligibility Criteria:
Inclusion Criteria:
Age ≥18 years at the time of inclusion;
* Patient signed and dated written informed consent form (ICF) in accordance with ICH GCP and local legislation prior to inclusion in the study for the prospective observational cohort;
* Established diagnosis of hypertension, diagnosed in accordance with current clinical guidelines for hypertension, i.e. in adults, i.e. systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg. when measured at two different visits
* Laboratory markers of CKD (eGFR \<60 mL/min/1.73 m2 and/or albuminuria/proteinuria\*) measured during the period ≤12 months prior to inclusion in the study and persisting ≥3 months between two measurements without a recorded diagnosis of CKD in the primary medical record prior to inclusion;
\* any of the following: urine albumin/creatinine ratio (UACR) ≥30 mg/g (3 mg/mmol), Urine protein-creatinine ratio (uPCR) ≥150 mg/g (15 mg/mmol), albuminuria ≥30 mg/d or Urine protein-creatinine ratio (uPCR) ≥0.15 mg/d.
* Absence of documented diagnosis of CKD in the patient's medical records prior to inclusion in the study
Exclusion Criteria:
* Absence of a signed ICF in patients in the prospective follow-up group
* Participation in any randomized controlled trial within 3 months prior to inclusion in this study or during participation in this study
* An established diagnosis of type 1 or type 2 diabetes mellitus.
* Diagnosis of symptomatic chronic heart failure (CHF), NYHA functional class III-IV, documented in the patient's medical records
* Diagnosis of AH of secondary genesis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06744335
Study Brief:
Protocol Section:
NCT06744335