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

September 25, 2019 updated by: Centre Hospitalier Universitaire de Nīmes

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nîmes, France, 30029
        • CHU de Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with renal insufficiency
Systolic blood pressure measured by Foot-to-Apex Systolic Interval, conventional oscillometric measurement, and the auscultatory method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure according to oscillometric curve
Time Frame: Day 0
mmHg measured by Systolic Foot-to-Apex Time Interval
Day 0
Systolic blood pressure according to Korotkov sounds
Time Frame: Day 0
mmHg measured by auscultatory method
Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Antonia Perez Martin, CHU Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2019

Primary Completion (Actual)

August 14, 2019

Study Completion (Actual)

August 14, 2019

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 26, 2019

Last Update Submitted That Met QC Criteria

September 25, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IDIL/2018/APM-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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