PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia

NCT06372431 | Recruiting

• 1 other identifier: D1843R00360
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Arterial Hypertension, Chronic Kidney Disease

Keywords

arterial hypertension, chronic kidney disease, CKD, AH

Outcome Measures

Primary Outcomes (1)

• To describe the rate of CKD diagnosis in patients with AH and CKD markers.

  1. Proportion of patients with AH and CKD markers and recorded CKD diagnosis based on retrospective data on Visit 1 ; See Note #1 below. 2. Proportion of patients with AH and CKD markers with confirmed and recorded CKD diagnosis during Visit 2. 3. Proportion of patients with AH and CKD markers to whom CKD diagnosis was not confirmed during Visit 2; 4. Total proportion of patients with confirmed CKD diagnosis in the study, i.e. during Visit 1 or Visit 2. Note #1: During Visit 1 (inclusion in the study) the demographic and clinical characteristics, including medical history, CKD markers, will be collected retrospectively from all enrolled patients. In case of enough retrospective data for the period of ≤12 months prior to inclusion to confirm CKD diagnosis according to the current clinical guidelines (two consecutive evaluations of CKD marker(s) with the interval between two measurements not less than 3 months), the CKD diagnosis can be confirmed and recorded during Visit 1.

  up to 18 months

Secondary Outcomes (2)

• To describe demographic and clinical characteristics of patients with AH and CKD markers

  18 months

• To describe clinical characteristics of patients with AH and diagnosed CKD during this study (on Visit 1 or Visit 2) and profile of routine therapy before and after CKD diagnosis

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

10 000 adult outpatients with AH, who have one or more CKD laboratory markers (without recorded CKD diagnosis prior to enrolment), and have no DM or CHF, who are monitored and treated by cardiologists or internal medicine specialists

You may qualify if:

• Male or female participants aged 18 years or older at the time of signing the ICF;
• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (30)

Research Site

Aramil, Russia

RECRUITING

Research Site

Chelyabinsk, Russia

RECRUITING

Research Site

Irkutsk, Russia

RECRUITING

Research Site

Kaluga, Russia

RECRUITING

Research Site

Kazan', Russia

RECRUITING

Research Site

Kemerovo, Russia

RECRUITING

Research Site

Krasnodar, Russia

RECRUITING

Research Site

Krasnoyarsk, Russia

RECRUITING

Research Site

Moscow, Russia

RECRUITING

Research Site

Nizhny Novgorod, Russia

COMPLETED

Research Site

Novosibirsk, Russia

RECRUITING

Research Site

Odintsovo, Russia

RECRUITING

Research Site

Omsk, Russia

RECRUITING

Research Site

Penza, Russia

RECRUITING

Research Site

Perm, Russia

RECRUITING

Research Site

Reutov, Russia

RECRUITING

Research Site

Rostov-on-Don, Russia

RECRUITING

Research Site

Ryazan, Russia

RECRUITING

Research Site

Saint Petersburg, Russia

RECRUITING

Research Site

Samara, Russia

RECRUITING

Research Site

Stavropol, Russia

RECRUITING

Research Site

Tomsk, Russia

RECRUITING

Research Site

Tula, Russia

RECRUITING

Research Site

Ufa, Russia

RECRUITING

Research Site

Ulan-Ude, Russia

RECRUITING

Research Site

Volgograd, Russia

RECRUITING

Research Site

Vologda, Russia

RECRUITING

Research Site

Voronezh, Russia

RECRUITING

Research Site

Yaroslavl, Russia

RECRUITING

Research Site

Yekaterinburg, Russia

RECRUITING

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: January 15, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

RU (30)