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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Kidney Transplant Patients

Intervention / Treatment
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* Other: Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements|Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements At D30 and D90 Measurement of systolic and diastolic blood pressure, impedancemetry, weight, 3 times a week between D30 and D90 post-transplant,|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypertension measurement | 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 | 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 | Weight will be measured only once at the inclusion consultation | day 30 | 
| Weight measurement | Weight will be measured at the end of the study . | Day 90 | 
| Weight measurement | 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 | 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 | Impedance measurement | 3 times a week | 
| Correlation between repeated self-measurements of extracellular hyperhydration | Weight | 3 times a week | 
| Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood | 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 | Composites criteria : Extracellular hyperhydration will be measured by impedance measurement Plasma creatinine and proBNP will mesuread by a blood test | Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hypervolemia, Self-measurement, Connected