PWV/CP/KTx: Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation

• Sponsor: Medical University of Warsaw (Other)
• Overall Status: Completed
• CT.gov ID: NCT02443454
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 4
• Patients Per Site Per Month: 24.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arterial Calcification; Aortic Stiffness; High Blood Pressure (& [Essential Hypertension])	Device: Device: Complior Analyse System; Device: Tanita BC 418- Bioelectrical impedance analysis

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Short and Long-term Results of Arterial Stiffness and Central Aortic Pressure After Kidney Transplantation
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Patients after kidney transplantation Short and Long-term results containing first 10 years after KTx.	Device: Device: Complior Analyse System; Monitoring of Arterial Stiffness and Central Aortic Pressure; Device: 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).
Healthy subjects Medical staff: medical doctors, nurses	Device: Device: Complior Analyse System; Monitoring of Arterial Stiffness and Central Aortic Pressure

Outcome Measures

Primary Outcome Measures

1. Differences in carotid-femoral pulse wave velocity [m/s] in short and long-term postoperative period. [1 day]

   Measurements will be performed in routine visits in Transplant Centre.

Secondary Outcome Measures

1. Differences in central aortic pressure [mmHg] in short and long-term postoperative period. [1 day]

   Measurements will be performed in routine visits in Transplant Centre.

2. Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] in short and long-term postoperative period. [1 day]

   Measurements will be performed in routine visits in Transplant Centre.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Warsaw	Warsaw	Mazovian	Poland	02-091

Sponsors and Collaborators

• Medical University of Warsaw

Investigators

• Study Chair: Łukasz Czyżewski, PhD, Medical University of Warsaw

Study Documents (Full-Text)

None provided.

More Information

Publications

• Czyżewski L, Sańko-Resmer J, Wyzgał 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.
• Czyżewski L, Sańko-Resmer J, Wyzgał 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.
• Czyżewski Ł, Wyzgał J, Kołek 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.

• Responsible Party: Łukasz Czyżewski, Łukasz Czyżewski, Medical University of Warsaw
• ClinicalTrials.gov Identifier: NCT02443454
• Other Study ID Numbers: PWV/CP/KTx/2015/05
• First Posted: May 13, 2015
• Last Update Posted: Oct 2, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Oct 2, 2015