Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04085094
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04085094
Study Brief:
Protocol Section:
NCT04085094