Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD)

Recruiting

• Conditions: Rate of CKD Diagnosis in Patients With AH and CKD Markers; Demographic and Clinical Characteristics for Those Patients; Routine Therapy Before and After the Diagnosis of CKD

• Registration Number: NCT06744335
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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):

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Status Verified: 2025-01
• Study Start: 2025-01-20
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1282

Inclusion Criteria

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 ≥3 and ≤12 months prior to inclusion in the study 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 total protein(protein)/creatinine ratio ≥150 mg/g (15 mg/mmol), albuminuria ≥30 mg/d or proteinuria ≥0.15 mg/d.

• Absence of documented diagnosis of CKD in the patient's medical records prior to inclusion in the study

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	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).

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
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	3. Proportion of patients with various clinical characteristics, such as: * Average and median duration of hypertension, years (from the diagnosis date to Visit 1); * Patients with different stages of hypertension (I, II, III) and categories of cardiovascular risk (low, moderate, high, very high).; * Patients with uncontrolled and resistant hypertension.
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	4. The proportion of patients taking the following groups of drugs for the treatment of hypertension before inclusion in the study and during participation in the study: * ACE (angiotensin-converting enzyme) inhibitors; * Beta-blockers; * ARBs (angiotensin receptor blockers); * Calcium channel blockers (CCB); * Diuretics (thiazide, thiazide-like, loop); * Angiotensin receptor-neprilysin inhibitor (ARNI); * Alpha-blockers; * Centrally acting drugs; * Mineralocorticoid receptor antagonists (MRA).
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	5. Proportion of patients with: * concomitant cardiovascular diseases (CVD) and complications of hypertension (atrial fibrillation/atrial flutter (AF/AFL), ventricular arrhythmias; coronary heart disease (CHD); myocardial infarction (MI); cerebrovascular diseases; stroke, transient ischemic attack (TIA); * other concomitant diseases (in general and for each disease).

Trial Locations

Locations (1)

Research Site; 🇰🇿 Temirlanovka Village, Kazakhstan