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
- Conditions
- Kidney Transplant Patients
- Registration Number
- NCT05039788
- Lead Sponsor
- Nantes University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between Hypertension and extracellular hyperhydration Day 90 Extracellular hyperhydration will be measured by impedance measurement
- Secondary Outcome Measures
Name Time Method Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood 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 testImpedance measurement 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.Weight measurement 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.
hypertension measurement 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.Correlation between repeated systolic and diastolic blood pressure self-measurements and patient weight 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.Correlation between repeated self-measurements of extracellular hyperhydration 3 times a week Weight
Correlation between repeated self-measurement of extracellular hyperhydration indices by impedancemetry and creatinemia and pro-BNP blood Day 90 Composites criteria :
Extracellular hyperhydration will be measured by impedance measurement Plasma creatinine and proBNP will mesuread by a blood test
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, Loire-Atlantique, France