Observational Single-center Study of the Relationship Between Arterial Hypertension and Hypervole… (NCT05039788) | Clinical Trial Compass
CompletedNot Applicable
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
France57 participantsStarted 2021-10-14
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Patients 1 to 6 months post-kidney transplant
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between Hypertension and extracellular hyperhydration
Timeframe: Day 90
2
Correlation between Hypertension and extracellular hyperhydration