End Stage Renal Disease Clinical Trial
Official title:
Longitudinal Change of Arterial Stiffness Indices in Relation to Ambulatory Aortic and Branchial Pressure in Long Term Peritoneal Dialysis Patients
NCT number | NCT03607747 |
Other study ID # | MedAuth |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 18, 2018 |
Est. completion date | August 30, 2020 |
This study evaluates the relationship between Ambulatory Aortic and Branchial blood pressure vs Office blood pressure measurements with the changes in arterial stiffness indices, in long-term Peritoneal Dialysis (PD) patients. These parameters will be monitored both cross-sectionally at the start of the study and prospectively over a 6 month period.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | August 30, 2020 |
Est. primary completion date | August 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 years old or higher 2. Renal replacement therapy with Peritoneal Dialysis (Automated or Continuous Ambulatory) for at least 3 months prior to study enrollment 3. Patient to have provided informed written consent Exclusion Criteria: 1. Ongoing atrial fibrillation 2. Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months 3. Recent episode of PD-related peritonitis or exit site infection 1 month or less prior to study enrollment 4. Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used earlier for dialysis access in patients previously treated with hemodialysis 5. Body mass index (BMI) of >40 kg/m2 6. History of malignancy or any other clinical condition associated with very poor prognosis |
Country | Name | City | State |
---|---|---|---|
Greece | AHEPA University Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity | 24-hour ambulatory Branchial vs office Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period | 6 months | |
Secondary | 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity | 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period | 6 months | |
Secondary | Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity | Assessing the correlation between the short-term variability of 24-hour ambulatory Branchial and Aortic SBP with the changes in Pulse Wave Velocity at the start of the study and over a 6 month period | 0, 6 months | |
Secondary | Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity | Assessing the predictive value of visit-to-visit variability of Branchial SBP for the changes in Pulse Wave Velocity over a 6 month period | 6 months | |
Secondary | Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients | Assessing whether or not office blood pressure measurements can diagnose hypertension or control of hypertension, based on the 24-hour ambulatory recordings | 0, 6 months | |
Secondary | The effect of overhydration on 24-hour ambulatory measurements | The correlation between overhydration (defined by the measurement of fluid status using Bioelectrical Impendence Analysis) and the 24-hour ambulatory Aortic and Branchial SBP measurements at the start of the study and over a 6 month period | 0, 3, 6 months |
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