Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372431
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-15
Brief Title:
PRospectIve ObseRvatIonal mulTicenter Study of Patients With Arterial hYpertension and CKD in the Population of Russia
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Multicenter Non-interventional Observational Prospective Study With Retrospective Analysis to Describe the Rate of CKD Diagnosis in Patients With Arterial Hypertension and CKD Markers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRIORITY-CKD
Brief Summary:
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 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
This observational study does not provide for any diagnostic and therapeutic procedures other than those used in routine practice
Detailed Description:
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 andor 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 heart failure that will allow focusing on evaluating the prevalence of newly diagnosed CKD in patients with hypertension
This study is a multi-centre non-interventional observational prospective study with retrospective analysis
Planned study population for prospective analysis consists of 10 000 adult outpatients with AH and one or more CKD markers without recorded CKD diagnosis prior to enrolment and without recorded diagnosis of DM or chronic heart failure CHF Planned number of study sites is 50 outpatient sites in about 20 regions of Russia
Retrospective part includes retrospective review by the physician of paper or electronic medical records of patients with recorded diagnosis of AH for the presence of laboratory CKD markers measured within the period of 3 and 12 months prior to inclusion into the study Patients with one or more CKD markers recorded in their medical records without recorded CKD diagnosis can be included in the prospective part of the study
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 3 and 12 months prior to inclusion to confirm CKD diagnosis according to the current clinical guidelines two consecutive evaluations of CKD markers with the interval between two measurements not less than 3 months the CKD diagnosis can be confirmed and recorded Otherwise the laboratory testing will be performed to confirm or exclude the CKD diagnosis
Overall expected duration of the study from the first patient inclusion to the last patient last visit is 18 months or until 10 000 eligible patients are included to the study and data on these patients are collected whichever occurs first
This non-interventional study does not imply any intervention into a routine clinical practice and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice
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 andor 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 heart failure that will allow focusing on evaluating the prevalence of newly diagnosed CKD in patients with hypertension
This study is a multi-centre non-interventional observational prospective study with retrospective analysis
Planned study population for prospective analysis consists of 10 000 adult outpatients with AH and one or more CKD markers without recorded CKD diagnosis prior to enrolment and without recorded diagnosis of DM or chronic heart failure CHF Planned number of study sites is 50 outpatient sites in about 20 regions of Russia
Retrospective part includes retrospective review by the physician of paper or electronic medical records of patients with recorded diagnosis of AH for the presence of laboratory CKD markers measured within the period of 3 and 12 months prior to inclusion into the study Patients with one or more CKD markers recorded in their medical records without recorded CKD diagnosis can be included in the prospective part of the study
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 3 and 12 months prior to inclusion to confirm CKD diagnosis according to the current clinical guidelines two consecutive evaluations of CKD markers with the interval between two measurements not less than 3 months the CKD diagnosis can be confirmed and recorded Otherwise the laboratory testing will be performed to confirm or exclude the CKD diagnosis
Overall expected duration of the study from the first patient inclusion to the last patient last visit is 18 months or until 10 000 eligible patients are included to the study and data on these patients are collected whichever occurs first
This non-interventional study does not imply any intervention into a routine clinical practice and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None