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End Stage Renal DiseaseNCT03607747

Relationship Between Blood Pressure and Pulse Wave Velocity Measurements in Peritoneal Dialysis

An observational study of End Stage Renal Disease and Peritoneal Dialysis, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the relationship between Ambulatory Aortic and Branchial blood pressure vs Office blood pressure measurements with the changes in arterial stiffness indices, in long-term Peritoneal Dialysis (PD) patients. Read more about this study

Who is it for?
Ages 18 years and older
How many people
40 participants
Where
1 siteGreece
Study dates
18 Jul 2018to 30 Aug 2020
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: 40 patients with end stage renal disease receiving peritoneal dialysis for more than 3 months.

Who may be able to join

  • Age 18 years old or higher
  • Renal replacement therapy with Peritoneal Dialysis (Automated or Continuous Ambulatory) for at least 3 months prior to study enrollment
  • Patient to have provided informed written consent

Who cannot join

  • Ongoing atrial fibrillation
  • Hospitalization for acute myocardial infarction, unstable angina or acute ischemic stroke within the 3 previous months
  • Recent episode of PD-related peritonitis or exit site infection 1 month or less prior to study enrollment
  • Bilateral functioning or non-functioning arteriovenous fistula (AVF) and/or arteriovenous graft (AVG) used earlier for dialysis access in patients previously treated with hemodialysis
  • Body mass index (BMI) of >40 kg/m2
  • History of malignancy or any other clinical condition associated with very poor prognosis

Trial locations and contacts

1 site in 1 country.

Vasileios Vaios, MD contact

+306984568904

vvaios_85@yahoo.gr

Greece1 site, 1 recruiting

  • AHEPA University Hospital

    Thessaloniki, 54621

    Vasileios Vaios, MD

    Recruiting

Other trials in Greece

About this study

Official title: Longitudinal Change of Arterial Stiffness Indices in Relation to Ambulatory Aortic and Branchial Pressure in Long Term Peritoneal Dialysis Patients

This study evaluates the relationship between Ambulatory Aortic and Branchial blood pressure vs Office blood pressure measurements with the changes in arterial stiffness indices, in long-term Peritoneal Dialysis (PD) patients. These parameters will be monitored both cross-sectionally at the start of the study and prospectively over a 6 month period.

Read the detailed description

All participants will be monitored over a 6 month period during which 7 monthly visits will be performed. Brachial and aortic blood pressure (BP), wave reflection and arterial stiffness indices will be assessed with the brachial cuff-based oscillometric device Mobil-O-Graph NG (IEM, Stolberg, Germany). The above hemodynamic and arterial wall parameters will be measured for 24-hours on visits 1 (baseline) and 7 (month 6). The monitor will be set to obtain recordings 3 times/hour from 11:00 pm to 06:59 am and 2 times/hour from 07:00 am to 10:59 pm. Measurements will be used for the analysis if >80% of recordings were valid with no more than two non-consecutive day hours with fewer than two valid measurements, and no more than one night hour without valid recording, according to recommendations for ambulatory BP monitoring. Bioelectrical Impendance Analysis (BIA) with the Fresenius Body Composition Monitor (BCM - Fresenius Medical Care, Bad Homberg, Germany) will be performed on visits 1, 4 and 6 in order to assess the hydration status and body composition parameters of the participants.

Keywords
Arterial Stiffness, Pulse Wave Velocity, Peritoneal Dialysis
Medical subject headings
Kidney Failure, Chronic, Arteriosclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity

    24-hour ambulatory Branchial vs office Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period

    Measured: 6 months

Secondary outcomes (5)

  1. 24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP as determinants of Pulse Wave Velocity

    24-hour ambulatory Aortic SBP vs 24-hour ambulatory Branchial SBP: which measurement correlates stronger with the changes in Pulse Wave Velocity over a 6 month period

    Measured: 6 months

  2. Short-term variability of 24-hour ambulatory Branchial and Aortic SBP as a determinant of Pulse Wave Velocity

    Assessing the correlation between the short-term variability of 24-hour ambulatory Branchial and Aortic SBP with the changes in Pulse Wave Velocity at the start of the study and over a 6 month period

    Measured: 0, 6 months

  3. Visit-to-visit variability of Branchial SBP as a determinant of Pulse Wave Velocity

    Assessing the predictive value of visit-to-visit variability of Branchial SBP for the changes in Pulse Wave Velocity over a 6 month period

    Measured: 6 months

  4. Office blood pressure monitoring for the diagnosis of hypertension in peritoneal dialysis patients

    Assessing whether or not office blood pressure measurements can diagnose hypertension or control of hypertension, based on the 24-hour ambulatory recordings

    Measured: 0, 6 months

  5. The effect of overhydration on 24-hour ambulatory measurements

    The correlation between overhydration (defined by the measurement of fluid status using Bioelectrical Impendence Analysis) and the 24-hour ambulatory Aortic and Branchial SBP measurements at the start of the study and over a 6 month period

    Measured: 0, 3, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study start18 Jul 2018
  3. Primary completion30 Aug 2020 (estimated)
  4. Study completion30 Aug 2020 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03607747
Sponsor's protocol ID
MedAuth
Status last verified
Jan 2020
First submitted
24 Jul 2018
Last updated
7 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med. 2004 Sep 23;351(13):1296-305. doi: 10.1056/NEJMoa041031.

    PubMed 15385656

  • Tonelli M, Wiebe N, Culleton B, House A, Rabbat C, Fok M, McAlister F, Garg AX. Chronic kidney disease and mortality risk: a systematic review. J Am Soc Nephrol. 2006 Jul;17(7):2034-47. doi: 10.1681/ASN.2005101085. Epub 2006 May 31.

    PubMed 16738019

  • Briet M, Boutouyrie P, Laurent S, London GM. Arterial stiffness and pulse pressure in CKD and ESRD. Kidney Int. 2012 Aug;82(4):388-400. doi: 10.1038/ki.2012.131.

    PubMed 22534962

  • Georgianos PI, Sarafidis PA, Lasaridis AN. Arterial stiffness: a novel cardiovascular risk factor in kidney disease patients. Curr Vasc Pharmacol. 2015;13(2):229-38. doi: 10.2174/15701611113119990147.

    PubMed 24007427

  • Blacher J, Guerin AP, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness on survival in end-stage renal disease. Circulation. 1999 May 11;99(18):2434-9. doi: 10.1161/01.cir.99.18.2434.

    PubMed 10318666

  • Sipahioglu MH, Kucuk H, Unal A, Kaya MG, Oguz F, Tokgoz B, Oymak O, Utas C. Impact of arterial stiffness on adverse cardiovascular outcomes and mortality in peritoneal dialysis patients. Perit Dial Int. 2012 Jan-Feb;32(1):73-80. doi: 10.3747/pdi.2010.00186. Epub 2011 Mar 31.

    PubMed 21454392

  • Szeto CC, Kwan BC, Chow KM, Leung CB, Law MC, Li PK. Prognostic value of arterial pulse wave velocity in peritoneal dialysis patients. Am J Nephrol. 2012;35(2):127-33. doi: 10.1159/000335580. Epub 2012 Jan 11.

    PubMed 22236995

  • Briet M, Collin C, Karras A, Laurent S, Bozec E, Jacquot C, Stengel B, Houillier P, Froissart M, Boutouyrie P; Nephrotest Study Group. Arterial remodeling associates with CKD progression. J Am Soc Nephrol. 2011 May;22(5):967-74. doi: 10.1681/ASN.2010080863. Epub 2011 Apr 14.

    PubMed 21493771

  • Kimoto E, Shoji T, Shinohara K, Hatsuda S, Mori K, Fukumoto S, Koyama H, Emoto M, Okuno Y, Nishizawa Y. Regional arterial stiffness in patients with type 2 diabetes and chronic kidney disease. J Am Soc Nephrol. 2006 Aug;17(8):2245-52. doi: 10.1681/ASN.2005101038. Epub 2006 Jul 12.

    PubMed 16837632

  • Townsend RR, Wimmer NJ, Chirinos JA, Parsa A, Weir M, Perumal K, Lash JP, Chen J, Steigerwalt SP, Flack J, Go AS, Rafey M, Rahman M, Sheridan A, Gadegbeku CA, Robinson NA, Joffe M. Aortic PWV in chronic kidney disease: a CRIC ancillary study. Am J Hypertens. 2010 Mar;23(3):282-9. doi: 10.1038/ajh.2009.240. Epub 2009 Dec 17.

    PubMed 20019670

  • Guerin AP, Blacher J, Pannier B, Marchais SJ, Safar ME, London GM. Impact of aortic stiffness attenuation on survival of patients in end-stage renal failure. Circulation. 2001 Feb 20;103(7):987-92. doi: 10.1161/01.cir.103.7.987.

    PubMed 11181474

  • Jung JY, Hwang YH, Lee SW, Lee H, Kim DK, Kim S, Oh YG, Yang J, Joo KW, Ahn C, Oh KH. Factors associated with aortic stiffness and its change over time in peritoneal dialysis patients. Nephrol Dial Transplant. 2010 Dec;25(12):4041-8. doi: 10.1093/ndt/gfq293. Epub 2010 May 25.

    PubMed 20501463

  • Utescu MS, Couture V, Mac-Way F, De Serres SA, Marquis K, Lariviere R, Desmeules S, Lebel M, Boutouyrie P, Agharazii M. Determinants of progression of aortic stiffness in hemodialysis patients: a prospective longitudinal study. Hypertension. 2013 Jul;62(1):154-60. doi: 10.1161/HYPERTENSIONAHA.113.01200. Epub 2013 May 6.

    PubMed 23648699

  • Agarwal R. Arterial stiffness and its relationship to clinic and ambulatory blood pressure: a longitudinal study in non-dialysis chronic kidney disease. Nephrol Dial Transplant. 2017 Nov 1;32(11):1850-1856. doi: 10.1093/ndt/gfw281.

    PubMed 27474747

  • Agarwal R, Brim NJ, Mahenthiran J, Andersen MJ, Saha C. Out-of-hemodialysis-unit blood pressure is a superior determinant of left ventricular hypertrophy. Hypertension. 2006 Jan;47(1):62-8. doi: 10.1161/01.HYP.0000196279.29758.f4. Epub 2005 Dec 12.

    PubMed 16344376

Questions about this trial

What is this clinical trial studying?

An observational study of End Stage Renal Disease and Peritoneal Dialysis, run by Aristotle University Of Thessaloniki at 1 site in Greece.

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 3 inclusion and 6 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 7 Jan 2020. 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 Greece. 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 Vasileios Vaios, MD (+306984568904, vvaios_85@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

24-hour ambulatory Branchial vs office Branchial Systolic BP (SBP) as determinants of Pulse Wave Velocity (time frame: 6 months). 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 NCT03607747, which also lists 36 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 7 Jan 2020.

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