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

NCT ID: NCT04043871

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-05

Study Completion Date

2019-08-14

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Insufficiency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with renal insufficiency

Systolic blood pressure

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Systolic blood pressure

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technology Transfer Accelerator Offices _ SATT AxLR

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonia Perez Martin

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU de Nimes

Nîmes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35021175 (View on PubMed)

Other Identifiers

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2018-A03347-48

Identifier Type: OTHER

Identifier Source: secondary_id

IDIL/2018/APM-02

Identifier Type: -

Identifier Source: org_study_id

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