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Concordance Between the Foot-to-Apex Systolic Interval and the Auscultatory Method for Measurement of Brachial Systolic Pressure in Patients With Severe Renal Failure

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04043871
Acronym
SFATI-IRC
Enrollment
90
Registered
2019-08-02
Start date
2019-06-05
Completion date
2019-08-14
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

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.

Interventions

DIAGNOSTIC_TESTSystolic blood pressure

Systolic blood pressure measured by Foot-to-Apex Systolic Interval, conventional oscillometric measurement, and the auscultatory method

Sponsors

Technology Transfer Accelerator Offices _ SATT AxLR
CollaboratorUNKNOWN
Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic blood pressure according to oscillometric curveDay 0mmHg measured by Systolic Foot-to-Apex Time Interval
Systolic blood pressure according to Korotkov soundsDay 0mmHg measured by auscultatory method

Secondary

MeasureTime frameDescription
Brachial artery calcium scoreDay 0Measured by ultrasound of the arteries of the upper limb
Presence of arterial rigidityDay 0Yes/No, measured by Complior \> 10 m/s
Brachial pulse wave velocityDay 0m/s
Modification of antihypertensive treatment to maintain systolic tension between 110 and 130 mm HgDay 0Change in antihypertensive treatment following measurement
Disease-associated patient characteristicsDay 0Age, sex, diabetes, Chronic Renal Disease stage
Systolic blood pressure according to conventional oscillometric measurementDay 0mmHg; Dinamap

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026