Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05039788
Study type Observational
Source Nantes University Hospital
Contact Claire Garandeau, PH
Phone 33 (0) 2.40.08.74.44
Email claire.garandeau@chu-nantes.fr
Status Recruiting
Phase
Start date October 14, 2021
Completion date December 14, 2024

See also
  Status Clinical Trial Phase
Completed NCT01680952 - Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients Phase 4
Completed NCT06044558 - Effect of Azole/Echinocandin Use on Tacrolimus Pharmacokinetics
Completed NCT05115435 - The Effect of Neuro Linguistic Programming on COVID-19 Fear in Kidney Transplant N/A
Completed NCT03356522 - Study of Trabecular Bone Score (TBS) as a Fracture Risk Factor in Chronic Renal Failure N/A