Arterial CalcificationNCT02908139
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
An observational study of Arterial Calcification and Aortic Stiffness, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Calcification, Aortic Stiffness, High Blood Pressure
- What is being tested?
- BR-102 plus PWA and Tanita MC780 MA S
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 40 consecutive patients admitted to Transplant Centre to perform kidney transplantataion were included in this study.
Who may be able to join
- give voluntary consent to participate in the study
- no clinical cardiovascular disease during the 6 months preceding entry
Who cannot join
- not meet the above criteria
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Mazowian, 02-091
Lukasz Czyzewski, PhD, 696457655 ext. 48, czyzewski_lukasz@wp.pl
Lukasz Czyzewski, PhD
About this study
Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation
- Being tested
- BR-102 plus PWA, Tanita MC780 MA S
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR-102 plus PWADevice
Monitoring of Arterial Stiffness and Central Aortic Pressure
Tanita MC780 MA SDevice
The device measured the size of total body water (TBW), Extra Cellular Water (ECW), Intra Cellular Water (ICW), fat mass (FM%), visceral fat%, fat free mass (FFM) and basal metabolic rate, (BMR) (kcal).
| Study group | Role | What they receive |
|---|---|---|
| Patients before kidney transplantation | The study included who had been admitted to the TransplantClinic before kidney transplantation Receives: Device: BR-102 plus PWA; Device: Tanita MC780 MA S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in pulse wave velocity [m/s] in short postoperative period.
Assessment will be performed one day before kidney transplantation and two days after kidney transplantation
Measured: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Secondary outcomes (1)
Differences in central aortic pressure [mmHg] in short postoperative period.
Assessment will be performed one day before kidney transplantation and two days after kidney transplantation
Measured: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arterial CalcificationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Czyżewski, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908139
- Sponsor's protocol ID
- PWV/KTx/2016/09
- Status last verified
- Jun 2017
- First submitted
- 12 Sep 2016
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Czyzewski L, Wyzgal J, Czyzewska E, Kurowski A, Sierdzinski J, Truszewski Z, Szarpak L. Assessment of Arterial Stiffness, Volume, and Nutritional Status in Stable Renal Transplant Recipients. Medicine (Baltimore). 2016 Feb;95(6):e2819. doi: 10.1097/MD.0000000000002819.
PubMed 26871855Czyzewski 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 25365639Czyzewski 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT02908139
- Acronym / sponsor ID
- PWV/KTx/2016/09
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients before kidney transplantation | – | Device: BR-102 plus PWA, Device: Tanita MC780 MA SThe study included who had been admitted to the TransplantClinic before kidney transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 40 consecutive patients admitted to Transplant Centre to perform kidney transplantataion were included in this study.
Key inclusion criteria (2 listed)
- give voluntary consent to participate in the study
- no clinical cardiovascular disease during the 6 months preceding entry
Key exclusion criteria (1 listed)
- not meet the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR-102 plus PWAMonitoring of Arterial Stiffness and Central Aortic Pressure | Device | Patients before kidney transplantation |
| Tanita MC780 MA SThe device measured the size of total body water (TBW), Extra Cellular Water (ECW), Intra Cellular Water (ICW), fat mass (FM%), visceral fat%, fat free mass (FFM) and basal metabolic rate, (BMR) (kcal). | Device | Patients before kidney transplantation |
Primary outcome
Differences in pulse wave velocity [m/s] in short postoperative period.
Time frame: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Assessment will be performed one day before kidney transplantation and two days after kidney transplantation
1 secondary outcome
Differences in central aortic pressure [mmHg] in short postoperative period.
Time frame: 3 days (one day before kidney transplantation and two days after kidney transplantation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Results publication: PubMed 26871855Czyzewski L, Wyzgal J, Czyzewska E, Kurowski A, Sierdzinski J, Truszewski Z, Szarpak L. Assessment of Arterial Stiffness, Volume, and Nutritional Status in Stable Renal Transplant Recipients. Medicine (Baltimore). 2016 Feb;95(6):e2819. doi: 10.1097/MD.0000000000002819.
- Results publication: PubMed 25365639Czyzewski 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.
- Results publication: PubMed 24770703Czyzewski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Calcification and Aortic Stiffness, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukasz Czyzewski, PhD (696457655 ext. 48, czyzewski_lukasz@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in pulse wave velocity [m/s] in short postoperative period. (time frame: 3 days (one day before kidney transplantation and two days after kidney transplantation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908139, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.