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

NCT05039788 | Recruiting

• 1 other identifier: RC20_0484
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Patients

Keywords

Hypertension; Hypervolemia; Self-measurement; Connected

Outcome Measures

Primary Outcomes (2)

• Correlation between Hypertension and extracellular hyperhydration

  Hypertension will be assessed by measurement of blood pressure

  Day 90

• Correlation between Hypertension and extracellular hyperhydration

  Extracellular hyperhydration will be measured by impedance measurement

  Day 90

Secondary Outcomes (10)

• hypertension measurement

  For 3 month post-transplant

• Impedance measurement

  For 3 month post-transplant

• Weight measurement

  day 30

• Weight measurement

  Day 90

• Weight measurement

  3 days a week between the 30th and the 90th day after transplantation.

Interventions

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,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• History of non-renal transplantation
• Minors, adults under guardianship and protected persons

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

MeSH Terms

Conditions

Hypertension; Edema

Interventions

Blood Pressure; Weights and Measures

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Investigative Techniques

Study Officials

• Claire GARANDEAU, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Garandeau, PH

CONTACT

33 (0) 2.40.08.74.44; claire.garandeau@chu-nantes.fr

Emmanuelle Papuchon

CONTACT

02.40.08.77.82; emmanuelle.papuchon@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: September 10, 2021
• Study Start: October 14, 2021
• Primary Completion: October 14, 2025
• Study Completion (Estimated): August 10, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)