NCT06744335已完成不适用
Prospective Observational Multicenter Study of Patients With Arterial Hypertension and Chronic Kidney Disease Markers in Kazakhstan (PROGRESS-CKD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,283
- 试验地点
- 29
- 主要终点
- 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).
研究概览
简要总结
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
详细描述
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):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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
排除标准
- •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
结局指标
主要结局
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).
时间窗: 16 months
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).
次要结局
- 1. Frequency of microalbuminuria, proteinuria, reduced glomerular filtration rate (GFR <60 ml/min/1.73 m²) and other markers of kidney damage in patients with arterial hypertension.(16 months)
- 2. Proportion of patients with various risk factors (age, gender, BMI, bad habits, blood pressure, cardiovascular risks) for the development and progression of CKD in patients with arterial hypertension.(16 months)
- 3.Proportion of patients with various clinical characteristics, such as: • Average and median duration of AH years • Patients with different stages of AH and categories of cardiovascular risk.• Patients with uncontrolled and resistant hypertension.(16 months)
- 4. The proportion of patients taking the following groups of drugs for the treatment of AH before inclusion in the study and during participation in the study: • ACE • Alfa or Beta-blockers; • ARBs •CCB • Diuretics • ARNI• Centrally acting drugs; • MRA.(16 months)
- 5. Proportion of patients with: • concomitant CVD and complications of AF/AFL, ventricular arrhythmias; CHD; MI; cerebrovascular diseases; stroke, TIA; • other concomitant diseases (in general and for each disease).(16 months)
- 1. Frequency of microalbuminuria, proteinuria, reduced glomerular filtration rate (GFR <60 ml/min/1.73 m²) and other markers of kidney damage in patients with arterial hypertension.(16 months)
- 2. Proportion of patients with various risk factors (age, gender, BMI, bad habits, blood pressure, cardiovascular risks) for the development and progression of CKD in patients with arterial hypertension.(16 months)
- 3.Proportion of patients with various clinical characteristics, such as: • Average and median duration of AH years • Patients with different stages of AH and categories of cardiovascular risk.• Patients with uncontrolled and resistant hypertension.(16 months)
- 4. The proportion of patients taking the following groups of drugs for the treatment of AH before inclusion in the study and during participation in the study: • ACE • Alfa or Beta-blockers; • ARBs •CCB • Diuretics • ARNI• Centrally acting drugs; • MRA.(16 months)
- 5. Proportion of patients with: • concomitant CVD and complications of AF/AFL, ventricular arrhythmias; CHD; MI; cerebrovascular diseases; stroke, TIA; • other concomitant diseases (in general and for each disease).(16 months)
研究者
研究点 (29)
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