PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia
Multicenter, Non-interventional Observational Prospective Study With Retrospective Analysis to Describe the Rate of CKD Diagnosis, in Patients With Arterial Hypertension and CKD Markers
AstraZeneca
10,000 participants
Jan 15, 2024
OBSERVATIONAL
Conditions
Summary
This study is a multi-centre, non-interventional, observational, prospective study with retrospective analysis. The main purpose of the study is to describe the rate of CKD diagnosis in patients with AH and CKD markers. This study will include 10 000 adult outpatients with arterial hypertension, who have one or more Chronic Kidney Disease laboratory markers (without recorded CKD diagnosis prior to enrolment) and have no diabetes mellitus or symptomatic chronic heart failure, who are monitored and treated by cardiologists or internal medicine specialists in approximately 50 outpatient sites in about 20 regions in Russia. This observational study does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.
Eligibility
Inclusion Criteria5
- Male or female participants aged 18 years or older at the time of signing the ICF;
- Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;
- Diagnosis of AH (essential hypertension) previously established in accordance with current Russian "Clinical guidelines on arterial hypertension in adults", i.e. office systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg, measured on two different visits;
- Laboratory markers of CKD (eGFR \< 60 ml/min/1,73 m2 and/or albuminuria/proteinuria\*), measured for the period of ≤12 months prior to enrolment. \*any of the following: urine ACR (albumin/creatinine ratio) ≥ 30 mg/g (3 mg/mmol), urine PCR (protein/creatinine ratio) ≥150 mg/g (15 mg/mmol), 24-h albuminuria ≥30 mg/day or 24-h proteinuria ≥ 0.15 g/day.
- No CKD diagnosis recorded in a patient's medical documents prior to enrollment
Exclusion Criteria4
- The diagnosis of symptomatic chronic heart failure (CHF) II-IV functional class according to the NYHA classification ever recorded in a patient's medical documents;
- The diagnosis of diabetes mellitus (DM type 1 or DM type 2) recorded in a patient's medical documents;
- The diagnosis of AH of secondary origin;
- Participation in any randomized controlled trial within 3 months before the inclusion in this study or during the participation in this study.
Locations(30)
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NCT06372431