NCT05039788招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation between Hypertension and extracellular hyperhydration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Patients 1 to 6 months post-kidney transplant
- •Isolated kidney transplant patient
- •BMI between 16 and 34 kg/cm2
- •Not opposed to the research
排除标准
- •History of non-renal transplantation
- •Patients treated with diuretics on the day of inclusion
- •Minors, adults under guardianship and protected persons
结局指标
主要结局
Correlation between Hypertension and extracellular hyperhydration
时间窗: Day 90
Hypertension will be assessed by measurement of blood pressure
次要结局
- Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood(Day 90)
- Impedance measurement(For 3 month post-transplant)
- Weight measurement(3 days a week between the 30th and the 90th day after transplantation.)
- hypertension measurement(For 3 month post-transplant)
- Correlation between repeated systolic and diastolic blood pressure self-measurements and patient weight(Day 90)
- Correlation between repeated self-measurement of extracellular hyperhydration indices by impedancemetry and creatinemia and pro-BNP blood(Day 90)
- Correlation between repeated self-measurements of extracellular hyperhydration(3 times a week)
- Weight measurement(day 30)
- Weight measurement(Day 90)
研究者
研究点 (1)
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