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

NCT04043871 | Completed

• 2 other identifiers: IDIL/2018/APM-022018-A03347-48
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Brachial pulse wave velocity

  Day 0

• Systolic blood pressure according to conventional oscillometric measurement

  Day 0

• Brachial artery calcium score

  Day 0

• Presence of arterial rigidity

  Day 0

• Disease-associated patient characteristics

  Day 0

Study Arms (1)

Patients with renal insufficiency

Diagnostic Test: Systolic blood pressure

Interventions

Systolic blood pressure DIAGNOSTIC_TEST

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

Patients with renal insufficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Technology Transfer Accelerator Offices _ SATT AxLR: collaborator

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 35021175 RESULT

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Antonia Perez Martin

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: June 5, 2019
• Primary Completion: August 14, 2019
• Study Completion: August 14, 2019
• Last Updated: December 1, 2025

Record last verified: 2019-05

Locations

FR (1)