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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systolic blood pressure

Diagnostic Test

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

Primary outcomes

  1. Systolic blood pressure according to oscillometric curve

    Time frame: Day 0

    mmHg measured by Systolic Foot-to-Apex Time Interval

  2. Systolic blood pressure according to Korotkov sounds

    Time frame: Day 0

    mmHg measured by auscultatory method

Secondary outcomes

  1. Brachial pulse wave velocity

    Time frame: Day 0

    m/s

  2. Systolic blood pressure according to conventional oscillometric measurement

    Time frame: Day 0

    mmHg; Dinamap

  3. Brachial artery calcium score

    Time frame: Day 0

    Measured by ultrasound of the arteries of the upper limb

  4. Presence of arterial rigidity

    Time frame: Day 0

    Yes/No, measured by Complior > 10 m/s

  5. Disease-associated patient characteristics

    Time frame: Day 0

    Age, sex, diabetes, Chronic Renal Disease stage

  6. Modification of antihypertensive treatment to maintain systolic tension between 110 and 130 mm Hg

    Time frame: Day 0

    Change in antihypertensive treatment following measurement

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Technology Transfer Accelerator Offices _ SATT AxLR

Registry information

Official study 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

Acronym: SFATI-IRC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2019
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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