Relationship Between Blood Pressure and Pulse Wave Velocity Measurements in Peritoneal Dialysis

NCT03607747 | Unknown

• 1 other identifier: MedAuth
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Renal Disease; Peritoneal Dialysis; Arterial Sclerosis

Keywords

Arterial Stiffness; Pulse Wave Velocity; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity

  6 months

• Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity

  0, 6 months

• Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity

  6 months

• Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients

  0, 6 months

• The effect of overhydration on 24-hour ambulatory measurements

  0, 3, 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

40 patients with end stage renal disease receiving peritoneal dialysis for more than 3 months.

You may qualify if:

• Age 18 years old or higher
• Renal replacement therapy with Peritoneal Dialysis (Automated or Continuous Ambulatory) for at least 3 months prior to study enrollment
• Patient to have provided informed written consent

You may not qualify if:

• Ongoing atrial fibrillation
• Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
• Recent episode of PD-related peritonitis or exit site infection 1 month or less prior to study enrollment
• Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used earlier for dialysis access in patients previously treated with hemodialysis
• Body mass index (BMI) of \>40 kg/m2
• History of malignancy or any other clinical condition associated with very poor prognosis

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54621, Greece

RECRUITING

Related Publications (36)

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MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriosclerosis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vassilios Liakopoulos, MD, PhD

  Department of Medicine, Aristotle University of Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Vasileios Vaios, MD

CONTACT

+306984568904; vvaios_85@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Division of Nephrology and Hypertension, 1st Department of Medicine, AHEPA University Hospital

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: July 31, 2018
• Study Start: July 18, 2018
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

GR (1)