protocolSection identificationModule nctId: NCT06277336, orgStudyIdInfo id: 2023-01716; kt23ChristCrain3, briefTitle: Effects of Intravenous [Pyr1]Apelin-13 on Healthy Volunteers With Artificially Induced SIAD, acronym: ESCAPE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: Hyponatremia is a common electrolyte imbalance which often results from hormonal disregulation. The study aims to investigate whether the apelin hormone, which plays a role in regulating salt and water balance in the body, can be used to treat hyponatremia.The study will involve healthy volunteers who will be given a medication that causes their bodies to retain water, thus inducing a temporary hyponatremia state. The researchers will measure the volunteers' blood and urine electrolyte levels to see how these are influenced by apelin administration. As comparison, the same measurements will be done in volunteers dosed with placebo instead of apelin.The researchers believe that apelin may be able to help to correct hyponatremia by increasing urine output. If the study focused in the healthy volunteers population is successful, the investigators will assess the effect of apelin administration in patients with chronic hyponatremia.The study's hypothesis is that intravenous apelin will increase urinary excretion and sodium levels in healthy participants with artificially induced hyponatremia., conditionsModule conditions: SIAD - Syndrome of Inappropriate Antidiuresis, conditions: Hyponatremia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Apelin Low Dose, interventions name: Apelin High Dose, interventions name: Selected Apelin Dose, outcomesModule primaryOutcomes measure: Total urinary excretion (ml), secondaryOutcomes measure: Hourly and total urinary excretion (ml), secondaryOutcomes measure: Change in electrolyte free water clearance (ml/min), secondaryOutcomes measure: Change in free water clearance (ml/min), secondaryOutcomes measure: Change in plasma osmolality (mOsm/kg), secondaryOutcomes measure: Change in plasma sodium (mmol/l), secondaryOutcomes measure: Change in body weight (kg), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, status: RECRUITING, city: Basel, zip: 4031, country: Switzerland, contacts name: Mirjam Christ-Crain, Prof. Dr., role: CONTACT, phone: +41 61 328 70 80, email: Mirjam.Christ-Crain@usb.ch, contacts name: Mirjam Christ-Crain, Prof. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Sophie Monnerat, Dr. Med., role: SUB_INVESTIGATOR, contacts name: Julie Refardt, PD. Dr. Med., role: SUB_INVESTIGATOR, contacts name: Neeraj Dhaun, Dr., role: SUB_INVESTIGATOR, contacts name: Fiona A. Chapman, PhD, role: SUB_INVESTIGATOR, contacts name: Anthony P. Davenport, Prof., role: SUB_INVESTIGATOR, contacts name: Janet Maguire, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False