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

Renal Insufficiency Clinical Trial

— SFATI-IRC  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043871
• Other study ID #: IDIL/2018/APM-02
• Status: Completed
• Start date: June 5, 2019
• Est. completion date: August 14, 2019

Study information

• Verified date: May 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 14, 2019
• Est. primary completion date: August 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Technology Transfer Accelerator Offices _ SATT AxLR

Country where clinical trial is conducted

France, 

Outcome

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