NCT02443454

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

May 10, 2015

Last Update Submit

September 30, 2015

Conditions

Arterial CalcificationAortic StiffnessHigh Blood Pressure (& [Essential Hypertension])

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

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

    1 day

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

    1 day

Study Arms (2)

Patients after kidney transplantation

Short and Long-term results containing first 10 years after KTx.

Device: Device: Complior Analyse SystemDevice: Tanita BC 418- Bioelectrical impedance analysis

Healthy subjects

Medical staff: medical doctors, nurses

Device: Device: Complior Analyse System

Interventions

Device: Complior Analyse SystemDEVICE

Monitoring of Arterial Stiffness and Central Aortic Pressure

Healthy subjectsPatients after kidney transplantation
Tanita BC 418- Bioelectrical impedance analysisDEVICE

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).

Patients after kidney transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 100 consecutive patients admitted to routine visin in Transplant Centre and 30 healthy subjects were included in this study.

You may qualify if:

  • 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)

You may not qualify if:

  • not meet the above criteria
  • episode of illness (for example: infection)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw

Warsaw, Mazovian, 02-091, Poland

Location

Related Publications (3)

  • 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.

    PMID: 25365639BACKGROUND

  • 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.

    PMID: 24770703BACKGROUND

  • 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.

    PMID: 25382249BACKGROUND

MeSH Terms

Conditions

HypertensionEssential Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Łukasz Czyżewski, PhD

    Medical University of Warsaw

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Łukasz Czyżewski

Study Record Dates

First Submitted

May 10, 2015

First Posted

May 13, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 2, 2015

Record last verified: 2015-09

Locations

PL(1)