- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05039788
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)
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
Status
Conditions
Detailed Description
Evaluation parameters
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/).
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
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Claire Garandeau, PH
- Phone Number: 33 (0) 2.40.08.74.44
- Email: claire.garandeau@chu-nantes.fr
Study Contact Backup
- Name: Emmanuelle Papuchon
- Phone Number: 02.40.08.77.82
- Email: emmanuelle.papuchon@chu-nantes.fr
Study Locations
-
-
Loire-Atlantique
-
Nantes, Loire-Atlantique, France, 44093
- Recruiting
- Nantes University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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.
|
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
Sponsor
Investigators
- Principal Investigator: Claire GARANDEAU, PH, CHU de Nantes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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