- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04043871
Concordance Between the Foot-to-Apex Systolic Interval and the Auscultatory Method for Measurement of Brachial Systolic Pressure in Patients With Severe Renal Failure (SFATI-IRC)
September 25, 2019 updated by: Centre Hospitalier Universitaire de Nīmes
Concordance Between the Foot-to-Apex Systolic Interval and the Auscultatory Method for Measurement of Brachial Systolic Pressure in Patients With Severe Renal Failure: Pilot Study
The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method will be accurate for measurement of systolic blood pressure with marked arterial stiffness as seen in patients with severe renal impairment.
Also that the presence of arterial calcifications only changes the agreement between the SFATI method and the reference method (auscultatory method) if the calcifications are very severe.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nîmes, France, 30029
- CHU de Nîmes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population consists of patients with severe renal impairment (defined by a glomerular filtration rate <30 mL / min, assessment within previous 3 months), stage 4 or stage 5.
Patients will be selected during consultations in the Nephrology department or during dialysis sessions at the University Hospital of Nîmes.
Description
Inclusion Criteria:
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- Patient under consultation in the Nephrology for severe renal impairment (defined by a glomerular filtration rate <30 mL / min, assessment within previous 3 months)
Exclusion Criteria:
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with renal insufficiency
|
Systolic blood pressure measured by Foot-to-Apex Systolic Interval, conventional oscillometric measurement, and the auscultatory method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure according to oscillometric curve
Time Frame: Day 0
|
mmHg measured by Systolic Foot-to-Apex Time Interval
|
Day 0
|
Systolic blood pressure according to Korotkov sounds
Time Frame: Day 0
|
mmHg measured by auscultatory method
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brachial pulse wave velocity
Time Frame: Day 0
|
m/s
|
Day 0
|
Systolic blood pressure according to conventional oscillometric measurement
Time Frame: Day 0
|
mmHg; Dinamap
|
Day 0
|
Brachial artery calcium score
Time Frame: Day 0
|
Measured by ultrasound of the arteries of the upper limb
|
Day 0
|
Presence of arterial rigidity
Time Frame: Day 0
|
Yes/No, measured by Complior > 10 m/s
|
Day 0
|
Disease-associated patient characteristics
Time Frame: Day 0
|
Age, sex, diabetes, Chronic Renal Disease stage
|
Day 0
|
Modification of antihypertensive treatment to maintain systolic tension between 110 and 130 mm Hg
Time Frame: Day 0
|
Change in antihypertensive treatment following measurement
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Antonia Perez Martin, CHU Nîmes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2019
Primary Completion (Actual)
August 14, 2019
Study Completion (Actual)
August 14, 2019
Study Registration Dates
First Submitted
August 1, 2019
First Submitted That Met QC Criteria
August 1, 2019
First Posted (Actual)
August 2, 2019
Study Record Updates
Last Update Posted (Actual)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDIL/2018/APM-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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