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
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