Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

454 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-01

Study Completion Date

2013-12-15

Brief Summary

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Chronic kidney disease has become an important Public Health issue in most developed and developing countries, with increasing incidence and prevalence rates. The cost associated with chronic kidney disease patients is very high, derived from renal replacement therapy and the cost associated with the high cardiovascular risk of this population. Primary and secondary preventive measures are imperative. In this sense, the comprehension of mechanisms and biomarkers associated with CKD progression and mortality risk in this population is an important area of research. Cohort studies are important tools for testing risk factors and biomarkers. Currently, CKD cohorts, particularly of those not on dialysis, are few and restricted to North America and Europe.

The present study established a cohort of 454 CKD participants (not on dialysis) in Sao Paulo, Brazil, who will be followed for 7-10 years. Baseline data collection was wide, including medical history, diet (food frequency questionnaire), calcium score, echocardiography, pulse wave velocity, cardiac frequency variability, carotid intimal media thickness, retinography, and an extensive biobank. Follow-up is ongoing and made through annual telephone interviews including questions on death, hospitalizations, and need of renal replacement therapy (RRT). Vital status is investigated periodically by a hot-pursuit strategy.

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Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CKD-related outcomes

the study is observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients attending the outpatient service of Hospital das Clínicas, São Paulo, Brazil.
* ≥ 30 years.
* at least two measurements of creatinine (with a minimum interval of 3 months) ≥ 1.6 mg/dl for men and ≥ 1.4 mg/ dl for women.

Exclusion Criteria

* Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis and glomerulonephritis services were excluded.
* hospitalization within the last six months;
* acute myocardial infarction within the last six months;
* autoimmune diseases;
* current pregnancy;
* psychiatric diseases;
* ongoing chemotherapy or immunosuppressive therapy;
* current renal replacement therapy;
* HIV/AIDS infection;
* hepatitis B or C;
* any organ transplantation.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No