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Completed

NCT Number: NCT05039788

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

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.

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Key information

Conditions

Kidney Transplant Patients Cardiovascular Diseases Edema Hypertension Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements

Other

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,

Primary outcomes

  1. Correlation between Hypertension and extracellular hyperhydration

    Time frame: Day 90

    Hypertension will be assessed by measurement of blood pressure

  2. Correlation between Hypertension and extracellular hyperhydration

    Time frame: Day 90

    Extracellular hyperhydration will be measured by impedance measurement

Secondary outcomes

  1. hypertension measurement

    Time frame: 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.

  2. Impedance measurement

    Time frame: 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.

  3. Weight measurement

    Time frame: day 30

    Weight will be measured only once at the inclusion consultation

  4. Weight measurement

    Time frame: Day 90

    Weight will be measured at the end of the study .

  5. Weight measurement

    Time frame: 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.

  6. Correlation between repeated systolic and diastolic blood pressure self-measurements and patient weight

    Time frame: 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.

  7. Correlation between repeated self-measurements of extracellular hyperhydration

    Time frame: 3 times a week

    Impedance measurement

  8. Correlation between repeated self-measurements of extracellular hyperhydration

    Time frame: 3 times a week

    Weight

  9. Correlation between repeated self-measurement of systolic and diastolic blood pressure and creatinemia and pro-BNP blood

    Time frame: 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 test

  10. Correlation between repeated self-measurement of extracellular hyperhydration indices by impedancemetry and creatinemia and pro-BNP blood

    Time frame: Day 90

    Composites criteria :

    Extracellular hyperhydration will be measured by impedance measurement Plasma creatinine and proBNP will mesuread by a blood test

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: HTAôConnect

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2021
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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