Observational study of patients with high blood pressure and kidney disease in 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
This study is trying to find out how many people with high blood pressure also have kidney disease that hasn't been diagnosed yet, by looking at 10,000 adult patients in Russia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 30 sites (Aramil and 29 other locations) |
| Trial ID | NCT06372431 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of chronic kidney disease (CKD) among patients with arterial hypertension (AH) in Russia. It will enroll 10,000 adult outpatients who have laboratory markers indicating CKD but have not been previously diagnosed with the condition. The study will take place across approximately 50 outpatient sites in 20 regions of Russia, focusing on routine monitoring and treatment by cardiologists or internal medicine specialists. By tracking these patients over time, the study seeks to improve early detection of CKD and reduce associated health risks.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diagnosed arterial hypertension and laboratory markers of CKD, but without a prior CKD diagnosis.
Not a fit: Patients with diabetes mellitus or symptomatic chronic heart failure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and management of CKD in patients with arterial hypertension, potentially improving patient outcomes.
How similar studies have performed: While there is limited data on the specific population of patients with both AH and CKD in Russia, similar observational studies have shown success in other regions, indicating the potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female participants aged 18 years or older at the time of signing the ICF; 2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study; 3. 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; 4. 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. 5. No CKD diagnosis recorded in a patient's medical documents prior to enrollment Exclusion Criteria: 1. 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; 2. The diagnosis of diabetes mellitus (DM type 1 or DM type 2) recorded in a patient's medical documents; 3. The diagnosis of AH of secondary origin; 4. Participation in any randomized controlled trial within 3 months before the inclusion in this study or during the participation in this study.
Where this trial is running
Aramil and 29 other locations
- 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)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.