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

Completed

• Conditions: Renal Insufficiency
• Interventions: Diagnostic Test: Systolic blood pressure

• Registration Number: NCT04043871
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-06-05
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-02
• Primary Completion: 2019-08-14
• Study Completion: 2019-08-14
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with renal insufficiency	Systolic blood pressure	-

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure according to oscillometric curve	Day 0	mmHg measured by Systolic Foot-to-Apex Time Interval
Systolic blood pressure according to Korotkov sounds	Day 0	mmHg measured by auscultatory method

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France