Condition category
Circulatory System
Date applied
05/01/2016
Date assigned
09/01/2016
Last edited
07/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic periaortitis is a rare disease of unknown cause that leads to inflammatory tissue around the body's main artery, the aorta. It is known that increased arterial stiffness is associated with an increased risk of heart disease and death. We aim to study arterial stiffness in patients with chronic periaortitis.

Who can participate?
Patients with chronic periaortitis, patients with high blood pressure, and 16 healthy volunteers, matched for sex and age (age range: 34 to 74).

What does the study involve?
Participants have their arterial stiffness measured with two methods: pulse wave velocity (a probe placed over the neck artery and the main leg artery) and digital volume pulse (a probe placed on the index finger). We study the change of digital volume pulse before and after giving the patients the drug nitroglycerin sublingually (under the tongue).

What are the possible benefits and risks of participating?
Benefits include knowing whether you have a marker of heart disease risk and contributing to knowledge about a very rare disease. Sublingual nitroglycerin can sometimes cause a headache, sickness and dizziness. These side effects usually last less than 10 minutes and are not dangerous.

Where is the study run from?
University Hospital of Bern (Switzerland).

When is the study starting and how long is it expected to run for?
January to May 2008.

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Claudia Scheuter

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claudia Scheuter

ORCID ID

http://orcid.org/0000-0001-7088-3652

Contact details

Department of Nephrology and Hypertension
Inselspital University Hospital
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1491

Study information

Scientific title

Arterial stiffness and vascular function in patients with chronic periaortitis – a case-control study

Acronym

Study hypothesis

Patients with periaortitis show an elevated arterial stiffness and a reduced vascular function

Ethics approval

Kantonale Ethikkommission Bern (Ethics Committee of the State of Bern, Switzerland), 07/04/2008, ref: 025/08

Study design

Observational cross-sectional case-control Study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic periaortitis, also known as Ormond’s disease or retroperitoneal fibrosis is a rare disease of unknown etiology with pathological features of vascular inflammation and fibrosis.

Intervention

We compared arterial stiffness and endothelial function in 16 patients with chronic periaortitis to age- and sex-matched hypertensive and healthy controls in a 1:1 distribution. Aortic stiffness was assessed by carotid-to-femoral pulse wave velocity with Doppler measurements. Endothelium-independent vasodilation was assessed before and after sublingual administration of glyceryl trinitrate by analyzing changes in arterial stiffness using digital volume pulse (DVP) and the DVP derived stiffness index (SIDVP).

Intervention type

Device

Phase

Drug names

Primary outcome measures

Arterial stiffness, measured by pulse wave velocity (PWV). PWV was recorded in a single session, using a Pulse Trace PWV© (Micro Medical Ltd, Rochester, Kent, UK) with a 4-MHz continuous wave directional Doppler pencil probe. Pulse Trace PWV© calculates the time lag between the R wave of the electrocardiogram and the arrival of the arterial pulse wave at 2 different sites, thus inferring pulse wave velocity. First, electrodes for an electrocardiogram are placed, followed by placing the Doppler probe over (1) the right carotid artery and (2) the right or left femoral artery. The position of the Doppler probe is optimized at each site to achieve a signal of sufficient quality (i.e. stable pulse waveform). About 10 systolic peaks are recorded at both sites to obtain a mean time lag at the carotid artery and at the femoral artery. The distance between the 2 detection sites is measured.

Secondary outcome measures

Digital volume pulse (DVP) as a measure for endothelial function, blood pressure, heart rate and pulse pressure. DVP was measured photoplethysmographically in the same single session as PWV, using the Pulse Trace© Pulse Contour Analysis device (Micro Medical Ltd, Rochester, Kent, UK). The probe were placed on the index finger of the dominant hand. Pulse contour waves recorded over a period of 10 seconds were averaged by the device to a single waveform. Blood pressure was measured while participants were recumbent for at least 10 minutes.

Overall trial start date

31/01/2008

Overall trial end date

30/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients: patients with a diagnosis of chronic periaortitis that were followed at our outpatient clinic for Nephrology and Hypertension and patients with known arterial hypertension that were followed at our outpatient clinic for Nephrology and Hypertension, matched for age and sex in a 1:1 fashion.

Healthy volunteers: healthy volunteers from the community and clinic staff, matched 1:1 for age and sex.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

45 - 50

Participant exclusion criteria

Patients with atrial fibrillation and other cardiac arrhythmias that interfered with study measurements

Recruitment start date

07/04/2008

Recruitment end date

30/05/2008

Locations

Countries of recruitment

Switzerland

Trial participating centre

Inselspital University Hospital Bern
Department of Nephrology and Hypertension
Bern
3010
Switzerland

Sponsor information

Organisation

Inselspital University Hospital Bern (Switzerland)

Sponsor details

Department of Nephrology and Hypertension
Bern
3010
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.nephrologie.insel.ch/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the results in an open-access medical journal.

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes