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CompletedNCT02443454PWV/CP/KTxUpdated Oct 2, 2015

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

An observational study in Arterial Calcification, Aortic Stiffness and High Blood Pressure (& [Essential Hypertension]), sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Medical University of Warsaw · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Arterial Calcification
  • Aortic Stiffness
  • High Blood Pressure (& [Essential Hypertension])
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 100 is below the median of 210 across 1,392 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 325 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • not meet the above criteria
  • episode of illness (for example: infection)
  • pregnancy
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients after kidney transplantation

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

    Device: Device: Complior Analyse System · Device: Tanita BC 418- Bioelectrical impedance analysis

  • Healthy subjects

    Medical staff: medical doctors, nurses

    Device: Device: Complior Analyse System

Interventions

  • DeviceDevice: Complior Analyse System

    Monitoring of Arterial Stiffness and Central Aortic Pressure

  • DeviceTanita 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).

06

What researchers measure

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.

    Time frame: 1 day

Secondary outcomes

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

    Measurements will be performed in routine visits in Transplant Centre.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

07

Study locations

1 site
  • Medical University of Warsaw
    Warsaw, Mazovian 02-091, Poland
08

References and documents

Publications

  • 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. PubMed 25365639 ↗
  • 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. PubMed 24770703 ↗
  • 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. PubMed 25382249 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of Sep 2015 and a completion of Sep 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2015
First posted
May 13, 2015
Start
May 2015
Primary completionActual
Sep 2015
CompletionActual
Sep 2015
Last update
Oct 2, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02443454
Responsible party
Łukasz Czyżewski (Łukasz Czyżewski, Medical University of Warsaw) — Principal investigator
First posted
May 13, 2015
Start date
May 2015
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Oct 2, 2015

Study contacts

Łukasz Czyżewski, PhD
study chair · Medical University of Warsaw

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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