Kidney Transplant PatientsHTAôConnectNCT05039788
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
An observational study of Kidney Transplant Patients, run by Nantes University Hospital at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Patients
- What is being tested?
- Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2021to 17 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- History of non-renal transplantation
- Patients treated with diuretics on the day of inclusion
- Minors, adults under guardianship and protected persons
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Kidney Transplant Patients
- Being tested
- Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements
- Keywords
- Hypertension, Hypervolemia, Self-measurement, Connected
- Medical subject headings
- Hypertension, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurementsOther
Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements At D30 and D90
Measurement of systolic and diastolic blood pressure, impedancemetry, weight, 3 times a week between D30 and D90 post-transplant,
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Hypertension and extracellular hyperhydration
Hypertension will be assessed by measurement of blood pressure
Measured: Day 90
Correlation between Hypertension and extracellular hyperhydration
Extracellular hyperhydration will be measured by impedance measurement
Measured: Day 90
Secondary outcomes (10)
hypertension measurement
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.
Measured: For 3 month post-transplant
Impedance measurement
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.
Measured: For 3 month post-transplant
Weight measurement
Weight will be measured only once at the inclusion consultation
Measured: day 30
Weight measurement
Weight will be measured at the end of the study .
Measured: Day 90
Weight measurement
The weight will be measured by self-measurement using DM certified scales.
Measured: 3 days a week between the 30th and the 90th day after transplantation.
Correlation between repeated systolic and diastolic blood pressure self-measurements and patient weight
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.
Measured: Day 90
Correlation between repeated self-measurements of extracellular hyperhydration
Impedance measurement
Measured: 3 times a week
Correlation between repeated self-measurements of extracellular hyperhydration
Weight
Measured: 3 times a week
Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood
Composites criteria :
Systolic and diastolic blood pressure will be assessed by measurement of blood pressure Plasma creatinine and proBNP will mesuread by a blood test
Measured: Day 90
Correlation between repeated self-measurement of extracellular hyperhydration indices by impedancemetry and creatinemia and pro-BNP blood
Composites criteria :
Extracellular hyperhydration will be measured by impedance measurement Plasma creatinine and proBNP will mesuread by a blood test
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start14 Oct 2021
- Primary completion17 Mar 2026
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant PatientsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire GARANDEAU, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039788
- Sponsor's protocol ID
- RC20_0484
- Acronym
- HTAôConnect
- Status last verified
- May 2026
- First submitted
- 8 Jun 2021
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05039788
- Acronym / sponsor ID
- HTAôConnect / RC20_0484
- Conditions
- Kidney Transplant Patients
- Keywords
- Hypertension, Hypervolemia, Self-measurement, Connected
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 17 Mar 2026 (actual)
- Study completion
- 17 Mar 2026 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- History of non-renal transplantation
- Patients treated with diuretics on the day of inclusion
- Minors, adults under guardianship and protected persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurementsMeasurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements At D30 and D90 Measurement of systolic and diastolic blood pressure, impedancemetry, weight, 3 times a week between D30 and D90 post-transplant, | Other | – |
Primary outcome
Correlation between Hypertension and extracellular hyperhydration
Time frame: Day 90
Hypertension will be assessed by measurement of blood pressure
Correlation between Hypertension and extracellular hyperhydration
Time frame: Day 90
Extracellular hyperhydration will be measured by impedance measurement
10 secondary outcomes
hypertension measurement
Time frame: For 3 month post-transplant
Impedance measurement
Time frame: For 3 month post-transplant
Weight measurement
Time frame: day 30
Weight measurement
Time frame: Day 90
Weight measurement
Time frame: 3 days a week between the 30th and the 90th day after transplantation.
Correlation between repeated systolic and diastolic blood pressure self-measurements and patient weight
Time frame: Day 90
Correlation between repeated self-measurements of extracellular hyperhydration
Time frame: 3 times a week
Correlation between repeated self-measurements of extracellular hyperhydration
Time frame: 3 times a week
Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood
Time frame: Day 90
Correlation between repeated self-measurement of extracellular hyperhydration indices by impedancemetry and creatinemia and pro-BNP blood
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire GARANDEAU, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant Patients, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Hypertension and extracellular hyperhydration (time frame: Day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.