HypertensionNCT00383968
Prevalence of Chronic KIdney Disease in Hypertensive Patients
An observational study of Hypertension and Chronic Kidney Disease, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Prevention of progressive renal disease needs a clear understanding of prevalence of early stage of chronic kidney disease in a community. Even in developed countries most subjects in early stages of chronic kidney disease go largely undiagnosed and untreated. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertension, Chronic Kidney Disease
- How many people
- 248 participants
- Where
- 1 sitePakistan
- Study dates
- Oct 2006to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known hypertensives aged 40 and above with microalbuminuria and/or elevated serum creatinine on first evaluation.
- Hypertension: Systolic blood pressure ≥140, and /or diastolic blood pressure ≥ 90 with or without antihypertensive drugs.
- Microalbuminuria:
- Albumin concentration of 20-200mg/L, with albumin-to-creatinine ratio of 3-30mg/mmol or 30-300mg/g
- Female: 3.0-30.0mg/mmol or 30-300mg/g
- Male: 2.0-20.0mg/mmol or 20
Show all 9Show fewer
- Elevated Serum creatinine:
- Female: >1.2mg/dl
- Male: >1.4mg/dl
Who cannot join
- Known diabetics will be excluded.
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh
Muslima A Ejaz, MBBS, 4604860 ext. 4860, muslima.ejaz@aku.edu
Tazeen H Jafar, MD, MPH, 4930051 ext. 4818, tazeen.jafar@aku.edu
About this study
Prevention of progressive renal disease needs a clear understanding of prevalence of early stage of chronic kidney disease in a community. Even in developed countries most subjects in early stages of chronic kidney disease go largely undiagnosed and untreated. Targeted screening could identify a greater numbers of individuals at risk then a general public screening (11). It is economically more feasible to perform in a country like Pakistan. Hypertension and diabetes are highly prevalent in South-Asia.It is anticipated that if target screening of hypertensive population is performed especially of an age group in which intervention might be expected to have maximal benefit it will not only help to identify from a large number of patients with essential hypertension destined to develop or in the course of advancing towards end stage renal disease but will also unearth mislabeled "essential hypertension" that have underlying primary renal disease. This later group may belong to socio-economic disadvantaged population who have limited access to health care and have never been investigated properly. The aim of the Study is to detect sub-clinical chronic kidney disease in hypertensive patients at community level and to identify associated risk factors.
Read the detailed description
This will be Cross sectional or prevalent study targeting diagnosed hypertensives aged 40 and above years, in middle to low socio-economic settings of Karachi. This proposed study will be nested in the existing Wellcome Trust funded study. The parent study is designed to determine the impact of a unique community versus high risk approach to control BP in Karachi, Pakistan In that ongoing Factorial design, individuals aged ≥40 who are found hypertensive in the 12 clusters (each containing 250 households) are being randomized to different interventions for their BP control. All participants enrolled in that study had urine examination for proteinuria and serum creatinine measurements at baseline to assess their renal status. For the proposed study the identified hypertensive (from parent study) who had either shown proteinuria and or had elevated serum creatinine (more then 1.2 for females and 1.4 mg/dl for males) at baseline will be approached. Serum creatinine levels exceeding above mentioned cut-off levels, are only reached when GFR is<60ml/min/m². As mentioned above in order to classify these subjects as having chronic kidney disease these abnormalities must be demonstrated to persist for at least three months. A repeat serum creatinine measurement and urine examination for proteinuria will be performed in the present study, by obtaining blood sample and urine sample respectively from these subjects. As a period of three months have already passed since the baseline investigations were done, all subjects who will show persistent abnormalities in either or both test will fall into chronic kidney disease group. The repeated testing to confirm presence of CKD will include, measurement of serum creatinine and urinary albumin/creatinine ratio (>30mg/g) in an untimed urine specimen. This method has been recommended as the preferred screening strategy. A set questionnaire will be filled by interviewing the patient and risk factors for the presence of renal disease will be analyzed based on this information.
The data collection will be done through structured questionnaire and diagnosis will be made on the basis of their persistently elevated kidney biomarkers.
- Conditions
- Hypertension, Chronic Kidney Disease
- Medical subject headings
- Hypertension, Renal Insufficiency, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 248 participants
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Tazeen H Jafar, MD, MPH, Study director, Aga Khan UniversityMuslima A Ejaz, MBBS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383968
- Sponsor's protocol ID
- 06GS009CHS
- Status last verified
- Oct 2006
- First submitted
- 3 Oct 2006
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chronic KIdney Disease in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00383968
- Acronym / sponsor ID
- 06GS009CHS
- Conditions
- Hypertension, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Dec 2006
- First posted
- 4 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevention of progressive renal disease needs a clear understanding of prevalence of early stage of chronic kidney disease in a community. Even in developed countries most subjects in early stages of chronic kidney disease go largely undiagnosed and untreated. Targeted screening could identify a greater numbers of individuals at risk then a general public screening (11). It is economically more feasible to perform in a country like Pakistan. Hypertension and diabetes are highly prevalent in South-Asia.It is anticipated that if target screening of hypertensive population is performed especially of an age group in which intervention might be expected to have maximal benefit it will not only help to identify from a large number of patients with essential hypertension destined to develop or in the course of advancing towards end stage renal disease but will also unearth mislabeled "essential hypertension" that have underlying primary renal disease. This later group may belong to socio-economic disadvantaged population who have limited access to health care and have never been investigated properly. The aim of the Study is to detect sub-clinical chronic kidney disease in hypertensive patients at community level and to identify associated risk factors.
Detailed description
This will be Cross sectional or prevalent study targeting diagnosed hypertensives aged 40 and above years, in middle to low socio-economic settings of Karachi. This proposed study will be nested in the existing Wellcome Trust funded study. The parent study is designed to determine the impact of a unique community versus high risk approach to control BP in Karachi, Pakistan In that ongoing Factorial design, individuals aged ≥40 who are found hypertensive in the 12 clusters (each containing 250 households) are being randomized to different interventions for their BP control. All participants enrolled in that study had urine examination for proteinuria and serum creatinine measurements at baseline to assess their renal status. For the proposed study the identified hypertensive (from parent study) who had either shown proteinuria and or had elevated serum creatinine (more then 1.2 for females and 1.4 mg/dl for males) at baseline will be approached. Serum creatinine levels exceeding above mentioned cut-off levels, are only reached when GFR is<60ml/min/m². As mentioned above in order to classify these subjects as having chronic kidney disease these abnormalities must be demonstrated to persist for at least three months. A repeat serum creatinine measurement and urine examination for proteinuria will be performed in the present study, by obtaining blood sample and urine sample respectively from these subjects. As a period of three months have already passed since the baseline investigations were done, all subjects who will show persistent abnormalities in either or both test will fall into chronic kidney disease group. The repeated testing to confirm presence of CKD will include, measurement of serum creatinine and urinary albumin/creatinine ratio (>30mg/g) in an untimed urine specimen. This method has been recommended as the preferred screening strategy. A set questionnaire will be filled by interviewing the patient and risk factors for the presence of renal disease will be analyzed based on this information.
The data collection will be done through structured questionnaire and diagnosis will be made on the basis of their persistently elevated kidney biomarkers.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Known hypertensives aged 40 and above with microalbuminuria and/or elevated serum creatinine on first evaluation.
- Hypertension: Systolic blood pressure ≥140, and /or diastolic blood pressure ≥ 90 with or without antihypertensive drugs.
- Microalbuminuria:
- Elevated Serum creatinine:
Key exclusion criteria (2 listed)
- Known diabetics will be excluded.
- unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tazeen H Jafar, MD, MPH study director
Aga Khan University
Muslima A Ejaz, MBBS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Chronic Kidney Disease, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muslima Ejaz A Ejaz, MBBS (4864860 ext. 4860, muslima.ejaz@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2006.