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)

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: Renal Insufficiency
• Intervention / Treatment: Diagnostic test: Systolic blood pressure

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with renal insufficiency	Diagnostic test: Systolic blood pressure; 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	mmHg measured by Systolic Foot-to-Apex Time Interval	Day 0
Systolic blood pressure according to Korotkov sounds	mmHg measured by auscultatory method	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brachial pulse wave velocity	m/s	Day 0
Systolic blood pressure according to conventional oscillometric measurement	mmHg; Dinamap	Day 0
Brachial artery calcium score	Measured by ultrasound of the arteries of the upper limb	Day 0
Presence of arterial rigidity	Yes/No, measured by Complior > 10 m/s	Day 0
Disease-associated patient characteristics	Age, sex, diabetes, Chronic Renal Disease stage	Day 0
Modification of antihypertensive treatment to maintain systolic tension between 110 and 130 mm Hg	Change in antihypertensive treatment following measurement	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Technology Transfer Accelerator Offices _ SATT AxLR
• Investigators: Principal Investigator: Antonia Perez Martin, CHU Nîmes

Publications and helpful links

General Publications

• Benmira AM, Moranne O, Prelipcean C, Pambrun E, Dauzat M, Demattei C, Perez-Martin A. Direct Determination rather than Oscillometric Estimation of Systolic Blood Pressure in Patients with Severe Chronic Kidney Disease. Am J Nephrol. 2022;53(1):41-49. doi: 10.1159/000520996. Epub 2022 Jan 12.

Study record dates

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): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Blood Pressure
• Other Study ID Numbers: IDIL/2018/APM-02; 2018-A03347-48 (Other Identifier: ANSM)

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