Multicenter, Non-interventional Observational Prospective Study With Retrospective Analysis to Describe the Rate of CKD Diagnosis, in Patients With Arterial Hypertension and CKD Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 9,914
- 试验地点
- 31
- 主要终点
- To describe the rate of CKD diagnosis in patients with AH and CKD markers.
研究概览
简要总结
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.
详细描述
Timely chronic kidney disease (CKD) detection is important for slowing or preventing of kidney function deterioration, reducing cardiovascular complications and mortality. Unfortunately, early-stage CKD is primarily asymptomatic, and due to lack of symptoms CKD is often diagnosed only in advanced stages.
There are limited epidemiological data of the overall CKD prevalence in Russia. In Russia there is Federal diabetes registry that includes data of diabetes kidney disease among others, so the population of patients with diabetes mellitus (DM) and CKD is more studied. Besides the diabetes, AH is also considered one of the major etiological factors for CKD development and progression, but the population of patients with AH and CKD is less studied. Available studies that assess renal function in patients with AH are cross-sectional with one-time assessment of kidney function. The diagnosis of CKD should be established, if CKD markers are observed over 3 or more months, so it is required to assess the markers of kidney function and/or kidney damage overtime to confirm chronic condition.
There is a need to conduct a large observational study in patients with AH and CKD markers to describe the rate of CKD diagnosis in this patient population. Recorded diagnosis of CKD is an important first step to reduce the risk of disease progression and minimize adverse clinical outcomes.
The current study will enroll patients with AH and without previously diagnosed DM and symptomatic heart failure that will allow focusing on evaluating the prevalence of newly diagnosed CKD in patients with hypertension.
This study is a multi-center, non-interventional, observational, prospective study with retrospective analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
To describe the rate of CKD diagnosis in patients with AH and CKD markers.
时间窗: up to 18 months
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.
次要结局
- 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)