NCT05273424Enrolling by invitation
Clinical Outcomes of Hemodialysis in Brazil (COHEBRA): a Prospective Cohort Study
Clinical Outcomes of Chronic Kidney Disease Patients on Hemodialysis in Brazil: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 10 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Introduction: Chronic kidney disease (CKD) is characterized by progressive decrease in glomerular filtration rate (GFR), eventually reaching the end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). The decrease in GFR is associated with a linear increase in cardiovascular mortality. Dysfunction of the autonomic nervous system (ANS) has been well documented in patients with CKD, especially in people with ESRD. The renal ischemia causes both the excessive activation of the renin-angiotensin-aldosterone system (RAAS) by increasing renin release, as sympathetic ANS, through the afferent sympathetic nerves. The overactivated RAAS and sympathetic SNA feedback each other, which contributes to cardiovascular disease (CVD) in CKD. Despite the involvement of these systems in the pathogenesis of CVD in CKD, drugs that block the RAAS or sympathetic SNA have shown heterogeneous effects in CVD in this population. A potential explanation is the genetic heterogeneity, such as the polymorphism in the gene for angiotensin converting enzyme (ACE).In addition, the inflammatory process associated with CKD is regarded as central player in the general degenerative changes backing CKD on HD shorter survival, which in many aspects is like accelerated aging. Skeletal muscles are also affected in a pattern like aging sarcopenia, with loss of function and mass. Objectives: to evaluate the impact of ECA gene polymorphism, HRV, body composition, functional capacity, muscle strength, inflammatory factors and other potential predictors on the survival of patients with CKD treated by HD in a single center in southern Brazil. Methodology: Prospective cohort study. The sample will consist of adult patients with CKD on HD longer than 90 days. Sociodemographic and clinical data is collected from clinical records. HRV analysis is performed using a Micromed@ electrocardiogram device® with a recording of the standard deviation of all normal intervals (SDNN), square root of the mean of the squares of the differences between consecutive intervals (RMSSD), low frequency band (LF) and high frequency (HF) after a midweek HD session. The polymorphism of the ECA gene was evaluated by polymerase chain reaction method in peripheral blood DNA sample. Muscle quality and thickness has been obtained by ultrasound. Functional capacity by 6-minute walking test and muscle strength by dynamometer. The data will be analyzed using Stata 15.0 statistical package.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 18 Oct 2021
- Start date
- 1 Jun 2017
- Primary completion date
- 1 Jun 2021
- Lead sponsor
- Catholic University of Pelotas
- Diseases
- Chronic kidney disease
- NCT number
- NCT05273424
What you commit to
- Study type: Observational
- Planned participants: 500
- From 1 Jun 2017 to the primary completion date, 1 Jun 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- According to outcomes evaluated
Who the study is looking for
- chronic kidney disease
- hemodialysis treatment for longer than 90 days
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitário São Francisco de Paula Coordinator of this site? Confirm its status | Pelotas | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.