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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Patients
Keywords: Hypertension
Hypervolemia
Self-measurement
Connected
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between Hypertension and extracellular hyperhydration
timeFrame: Day 90
measure: Correlation between Hypertension and extracellular hyperhydration
timeFrame: Day 90
Secondary outcomes:
measure: hypertension measurement
timeFrame: For 3 month post-transplant
measure: Impedance measurement
timeFrame: For 3 month post-transplant
measure: Weight measurement
timeFrame: day 30
measure: Weight measurement
timeFrame: Day 90
measure: Weight measurement
timeFrame: 3 days a week between the 30th and the 90th day after transplantation.
measure: Correlation between repeated systolic and diastolic blood pressure self-measurements and patient weight
timeFrame: Day 90
measure: Correlation between repeated self-measurements of extracellular hyperhydration
timeFrame: 3 times a week
measure: Correlation between repeated self-measurements of extracellular hyperhydration
timeFrame: 3 times a week
measure: Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood
timeFrame: Day 90
measure: Correlation between repeated self-measurement of extracellular hyperhydration indices by impedancemetry and creatinemia and pro-BNP blood
timeFrame: Day 90
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Claire GARANDEAU, PH
role: PRINCIPAL_INVESTIGATOR
References: