Demographic and Clinical Characteristics for Those Patients, Rate of CKD Diagnosis in Patients With AH and CKD Markers, Routine Therapy Before and After the Diagnosis of CKD
Conditions
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):
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 ≤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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Kazakhstan
Outcome results
None listed