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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Technology Transfer Accelerator Offices _ SATT AxLR
First posted: 2019-08-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure according to oscillometric curve
timeFrame: Day 0
measure: Systolic blood pressure according to Korotkov sounds
timeFrame: Day 0
Secondary outcomes:
measure: Brachial pulse wave velocity
timeFrame: Day 0
measure: Systolic blood pressure according to conventional oscillometric measurement
timeFrame: Day 0
measure: Brachial artery calcium score
timeFrame: Day 0
measure: Presence of arterial rigidity
timeFrame: Day 0
measure: Disease-associated patient characteristics
timeFrame: Day 0
measure: Modification of antihypertensive treatment to maintain systolic tension between 110 and 130 mm Hg
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Antonia Perez Martin
role: PRINCIPAL_INVESTIGATOR
References: