- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03393663
Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk (PROGREDIR)
Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk. A Cohort Study in a Brazilian Population
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.
연구 개요
연구 유형
등록 (실제)
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients attending the outpatient service of Hospital das Clínicas, São Paulo, a public university facility providing quaternary-level care for patients with chronic diseases, were invited to participate in this study. Initially, from the outpatient records, all patients aged
≥ 30 years and 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 were considered potential candidates. Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis and glomerulonephritis services were excluded. The remaining candidates were then contacted by phone and were invited to participate if they did not meet any exclusion criteria.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Mortality
기간: 7 years
|
Mortality of any cause, confirmed by official death certificates obtained through several health offices (PRO-AIM, Fundação SEADE and National Mortality Registry).
|
7 years
|
|
Renal replacement therapy
기간: 7 years
|
Initiation of any modality of renal replacement therapy, even if not permanently. Besides participant information, RRT will be ascertained through the city and state´s Registries (Sao Paulo State Registry of Dialysis and Transplantation, Sao Paulo City Registry of Dialysis and Transplantation). |
7 years
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Domingos MAM, Queiroz M, Lotufo PA, Bensenor IJ, Titan SMO. Serum RBP4 and CKD: Association with insulin resistance and lipids. J Diabetes Complications. 2017 Jul;31(7):1132-1138. doi: 10.1016/j.jdiacomp.2017.04.013. Epub 2017 Apr 18.
- Domingos MA, Moreira SR, Gomez L, Goulart A, Lotufo PA, Bensenor I, Titan S. Urinary Retinol-Binding Protein: Relationship to Renal Function and Cardiovascular Risk Factors in Chronic Kidney Disease. PLoS One. 2016 Sep 21;11(9):e0162782. doi: 10.1371/journal.pone.0162782. eCollection 2016.
- Domingos MAM, Goulart AC, Lotufo PA, Bensenor IJM, Titan SMO. Chronic kidney disease - determinants of progression and cardiovascular risk. PROGREDIR cohort study: design and methods. Sao Paulo Med J. 2017 Mar-Apr;135(2):133-139. doi: 10.1590/1516-3180.2016.0272261116. Epub 2017 Apr 20.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .