Overview
Multicenter, non-interventional PRospective Observational study with retrospective analysis to describe the rate of CKD diaGnosis in patients with aRtErial hypErtenSion and CKD markerS in Kazakhstan
Description
Primary endpoints:
The proportion of patients with markers of chronic kidney disease (CKD) among patients with arterial hypertension such as: albuminuria/proteinuria; GFR <60 ml/min/1.73 m2 (CFR categories C3a-C5).
Secondary endpoints:
The following secondary endpoints will be evaluated in all patients with AH and markers of CKD included in the study (Full Analysis Sampling - FAS) (Secondary Aim 1) and in the subgroup of patients with a diagnosis of CKD confirmed during the study (Modified Full Analysis Sampling - mFAS), i.e., at Visit 1 or
Visit 2 (Secondary Aim 2):
Eligibility
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