Status:
COMPLETED
Gender Differences in Renal Functioning and Disease
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
University Hospital, Geneva
Conditions:
Chronic Renal Failure
Healthy Controls
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of the GenderBOLD study is to shed light on the mechanisms responsible for women's lower susceptibility to developing and progressing chronic renal disease, using modern imaging techniques...
Detailed Description
Chronic kidney disease (CKD) affects about 10% of the adult population in Switzerland. Despite decades of research, the mechanisms involved in the development and progression of CKD remain unclear, a...
Eligibility Criteria
Inclusion
- Inclusion/exclusion Criteria:
- Inclusion criteria for healthy pre-menopausal women:
- Age ≥ 18 years old and \<50 years old.
- No drugs (psychoactive substances used for non-medical purposes) /medicine.
- Blood pressure \<135/85mmHg.
- Renal function (eGFR \>90ml/min/1.73m2) and absence of albuminuria.
- Regular menstrual cycle.
- No pregnancy.
- Understanding and signature of the informed consent.
- Inclusion criteria for pre-menopausal women with a chronic renal failure:
- Age ≥ 18 years old and \<50 years old.
- Possibility to stop the treatment during the day of the study.
- Reduced renal function (eGFR 15-60 ml/min/1.73m2) or eGFR 60-90 ml/min/1.73m2 with the presence of albuminuria \>300 mg/j.
- Understanding and signature of the informed consent.
- Inclusion criteria for post-menopausal women:
- Age ≥ 50 years old.
- Absence of menstruation.
- No drugs consumption.
- No medicine, or possibility to stop it two days before the study.
- Blood pressure \<135/85mmHg.
- Renal function (eGFR \>90ml/min/1.73m2) and absence of albuminuria.
- Understanding and signature of the informed consent.
- Inclusion criteria for men:
- Age ≥ 18 years old, but matched with the age of pre- aor post-menopausal women
- No drugs consumption.
- No medicine, or possibility to stop it two days before the study.
- Blood pressure \<135/85mmHg.
- Renal function (eGFR \>90ml/min/1.73m2) and absence of albuminuria.
- Understanding and signature of the informed consent.
- Exclusion criteria for all:
- Contra-indication for Magnetic Resonance Imaging (Pacemaker, implanted metallic device, claustrophobia,..)
- Known allergy to one of the study compounds (furosemide, Sonovue).
- Exclusion criteria for persons with chronic renal failure:
- Autosomal dominant polycystic kidney disease.
- Ingestion of corticosteroids or other immunosuppressants.
- Volume overload or heart failure.
- eGFR \< 15ml/min/1.73m2 or dialysis.
- Exclusion criteria for men and women receiving sublingual nitroglycerin:
- Hypersensitivity to nitrous derivatives or to one of the excipients present in the composition.
- History of heart disease (ischemic heart disease, valve and/or rhythmic).
- Low blood pressure (systolic blood pressure \<100mmHg)
Exclusion
Key Trial Info
Start Date :
May 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 2 2019
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04085094
Start Date
May 30 2017
End Date
December 2 2019
Last Update
September 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHUV, nephrology service
Lausanne, Canton of Vaud, Switzerland, 1011