Observational Single-center Study of the Relationship Between Arterial Hypertension and Hypervolemia Defined by Self-measurement of Impedancemetry in Kidney Transplant Patients With Transplantation Less Than 6 Months Old (HTAôConnect)

January 3, 2023 updated by: Nantes University Hospital

Monocentric Observational Study to Determine the Relationship Between Arterial Hypertension and Hypervolaemia, Defined by Self-measurement of Impedancemetry in Kidney Transplant Recipients Under 6 Months Old

The working hypothesis is that hypertension during the first post-transplant trimester is partly explained by the patient's hypervolemia. The main objective of the single-center observational study "HTA ô Connect" is to study the relationship between hypertension and extracellular hyperhydration, thanks to repeated self-measurements of blood pressure and impedancemetry between the 30th and the 90th day post-transplant, in 150 incident kidney transplant patients from our department, the ITUN (Institute of Urology-Nephrology Transplantation).

The study population involves 150 incident kidney transplant patients, presenting to the Nantes University Hospital Transplant Institute for 1 month (D30), and presenting with hypertension ≥ 140/90mmHg and not treated with a diuretic.

Data collected at the patients' homes will be used to establish a relationship between blood pressure and extracellular water volume. The data collected will not be used to follow up patients who participated in the study in this first stage of exploration.

Study Overview

Detailed Description

Evaluation parameters

  1. Blood pressure :

    • At inclusion and at the end of the study (in consultation at D30 and D90, respectively), blood pressure will be measured 3 times after a few minutes of rest in a sitting position Hypertension in consultation will be defined by values > 140/90 mmHg.
    • Between D30 and D90, blood pressure will be measured by self-measurement using DM-certified devices, 3 times in the morning at breakfast and in the evening before bedtime, in a sitting position after a few minutes of rest. The operation will be repeated 3 days a week (Monday to Wednesday) between the 30th and the 90th day post-transplant. Self-measurement hypertension will be defined by values > 135/85 mmHg. Self-measurement blood pressure data will be directly transmitted to the "INTEGRALIS" specialty medical record of transplant patients at the ITUN via the epatient application (https://www.idbc.fr/e-patient/).
  2. Weight :

    • Weight will be measured only once at the inclusion consultation (D30) and at the end of the study (D90).
    • Between D30 and D90 the weight will be measured by self-measurement using DM certified scales. The operation will be repeated once in the morning and once in the evening at the time of blood pressure measurements, 3 days a week (Monday to Wednesday) between the 30th and the 90th day after transplantation. The data from the self-measurement of weight will be directly transmitted to the "INTEGRALIS" medical record of the transplanted patients at the ITUN
  3. Impedance measurement :

    • At inclusion and at the end of the study in consultation, respectively at D 30 and D90, impedancemetry will be measured once
    • Between D30 and D90, impedancemetry measurements will be collected at the same time as blood pressure measurements at the patients' homes by self-measurement 3 times in the morning and 3 times in the evening, 3 days a week (from Monday to Wednesday) between the 30th and the 90th day after transplantation. The impedancemetry will be collected with the help of a bluetooth-connected BIODYLIFEZM self-measurement device. The impedancemetry data collected via bluetooth will be directly transmitted to the "INTEGRALIS" specialty medical record of the transplanted patients at the ITUN.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Recruiting
        • Nantes University Hospital

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 involves 150 incident kidney transplant patients, presenting to the Nantes University Hospital Transplant Institute for 1 month (D30), and presenting with hypertension ≥ 140/90mmHg recorded in the outpatient clinic at the Nantes University Hospital, according to the recommendations of the French Society of Arterial Hypertension (6) and not treated with a diuretic.

There will be no emergency inclusion. Recently transplanted patients will come regularly, between 1 and 2 times per week, to the Nantes University Hospital during the first month. The study will be presented to them during this period and they will be included at the D30 (M1) consultation.

Description

Inclusion Criteria :

  • Age ≥ 18 years
  • Blood pressure ≥ 140/90mmHg on 3 occasions and according to the recommendations of the French Society of Hypertension (6) at the M1 consultation
  • Isolated kidney transplant patient
  • BMI between 16 and 34 kg/cm2
  • Not opposed to the research

Exclusion Criteria :

  • History of non-renal transplantation
  • Patients treated with diuretics on the day of inclusion
  • Minors, adults under guardianship and protected persons

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Hypertension and extracellular hyperhydration
Time Frame: Day 90
Hypertension will be assessed by measurement of blood pressure
Day 90
Correlation between Hypertension and extracellular hyperhydration
Time Frame: Day 90
Extracellular hyperhydration will be measured by impedance measurement
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypertension measurement
Time Frame: For 3 month post-transplant

Blood pressure :

At inclusion and at the end of the study (in consultation at Day 30 and Day 90, respectively), blood pressure will be measured 3 times after a few minutes of rest in a sitting position Hypertension in consultation will be defined by values > 140/90 mmHg.

• Between Day 30 and D90, blood pressure will be measured by self-measurement using DM-certified devices, 3 times in the morning at breakfast and in the evening before bedtime, in a sitting position after a few minutes of rest. The operation will be repeated 3 days a week (Monday to Wednesday) between the 30th and the 90th day post-transplant. Self-measurement hypertension will be defined by values > 135/85 mmHg.

For 3 month post-transplant
Impedance measurement
Time Frame: For 3 month post-transplant

At inclusion and at the end of the study in consultation, respectively at Day 30 and D90, impedancemetry will be measured once.

• Between Day 30 and Day 90, impedancemetry measurements will be collected at the same time as blood pressure measurements at the patients' homes by self-measurement 3 times in the morning and 3 times in the evening, 3 days a week (from Monday to Wednesday) between the 30th and the 90th day after transplantation.

For 3 month post-transplant
Weight measurement
Time Frame: day 30
Weight will be measured only once at the inclusion consultation
day 30
Weight measurement
Time Frame: Day 90
Weight will be measured at the end of the study .
Day 90
Weight measurement
Time Frame: 3 days a week between the 30th and the 90th day after transplantation.
The weight will be measured by self-measurement using DM certified scales.
3 days a week between the 30th and the 90th day after transplantation.
Correlation between repeated systolic and diastolic blood pressure self-measurements and patient weight
Time Frame: Day 90

blood pressure will be measured 3 times after a few minutes of rest in a sitting position Hypertension in consultation will be defined by values > 140/90 mmHg.

  • Between Day 30 and D90, blood pressure will be measured by self-measurement using DM-certified devices, 3 times a week.
  • Weight will be measured only once at the inclusion consultation (Day30) and at the end of the study (Day 90).
  • Between Day30 and Day 90 the weight will be measured by self-measurement using DM certified scales.
Day 90
Correlation between repeated self-measurements of extracellular hyperhydration
Time Frame: 3 times a week
Impedance measurement
3 times a week
Correlation between repeated self-measurements of extracellular hyperhydration
Time Frame: 3 times a week
Weight
3 times a week
Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood
Time Frame: Day 90

Composites criteria :

Systolic and diastolic blood pressure will be assessed by measurement of blood pressure Plasma creatinine and proBNP will mesuread by a blood test

Day 90
Correlation between repeated self-measurement of extracellular hyperhydration indices by impedancemetry and creatinemia and pro-BNP blood
Time Frame: Day 90

Composites criteria :

Extracellular hyperhydration will be measured by impedance measurement Plasma creatinine and proBNP will mesuread by a blood test

Day 90

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Claire GARANDEAU, PH, CHU de Nantes

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)

October 14, 2021

Primary Completion (Anticipated)

October 14, 2024

Study Completion (Anticipated)

December 14, 2024

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

August 31, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC20_0484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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