Clinical trial NCT06744335: Prospective Observational Multicenter Study of Patients With AH and CKD Markers in Kazakhstan (PROGRESS-CKD)
Official title: Prospective Observational Multicenter Study of Patients With Arterial Hypertension and Chronic Kidney Disease Markers in Kazakhstan (PROGRESS-CKD)
Study type: OBSERVATIONAL
Overall status: 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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 1282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The planned study population for the prospective analysis consists of 1,282 adult outpatients with AH with one or more markers of CKD, without a documented diagnosis of CKD before inclusion in the study and without a documented diagnosis of DM or III-IV stage chronic heart failure (CHF). The planned number of study centers is \~15 outpatient sites in approximately 10 regions of Kazakhstan.

The retrospective part includes a physician's retrospective review of the ambulatory cards or medical records of outpatients with a reported diagnosis of arterial hypertension for the presence of laboratory markers of CKD assessed ≥3 and ≤12 months prior to inclusion.

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):

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 16 months
Secondary outcomes:
measure: 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.
timeFrame: 16 months
measure: 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.
timeFrame: 16 months
measure: 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.
timeFrame: 16 months
measure: 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.
timeFrame: 16 months
measure: 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).
timeFrame: 16 months
Other outcomes:
Locations:
city: Temirlanovka Village
country: Kazakhstan
facility: Research Site
Study officials:
References: