Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation

Aortic Stiffness Clinical Trial

— PWV/CP/KTx  

Official title:

Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443454
• Other study ID #: PWV/CP/KTx/2015/05
• Status: Completed
• Phase: N/A
• First received: May 10, 2015
• Last updated: September 30, 2015
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Observational

Clinical Trial Summary

Central blood pressure and pulse wave velocity were measured using a Complior Analyse device in Short and Long-term after kidney transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• give voluntary consent to participate in the study

• functioning graft longer than 3 months to 10 years

• no clinical cardiovascular disease during the 6 months preceding entry

• stable graft function- glomerular filtration rate > 30 ml/min/1.73 m2, creatinine concentration <2.5 mg/dl

• medical staff (medical doctors, nurses)

Exclusion Criteria:

• not meet the above criteria

• episode of illness (for example: infection)

• pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Aortic Stiffness
• Arterial Calcification
• Calcinosis
• High Blood Pressure (& [Essential Hypertension])
• Hypertension
• Vascular Calcification

Intervention

Device:
• Device: Complior Analyse System
Monitoring of Arterial Stiffness and Central Aortic Pressure
• Tanita BC 418- Bioelectrical impedance analysis
The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265. — View Citation

Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248. — View Citation

Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in carotid-femoral pulse wave velocity [m/s] in short and long-term postoperative period.	Measurements will be performed in routine visits in Transplant Centre.	1 day	No
Secondary	Differences in central aortic pressure [mmHg] in short and long-term postoperative period.	Measurements will be performed in routine visits in Transplant Centre.	1 day	No
Secondary	Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] in short and long-term postoperative period.	Measurements will be performed in routine visits in Transplant Centre.	1 day	No