Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05542056
Status:
RECRUITING
Last Update Posted:
2025-07-01
First Post:
2022-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples and Urine aliquots are stored for eventual future research aims.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 232}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2022-09-12', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of hyponatremia (plasma sodium <135 mmol/L)', 'timeFrame': 'Within the first four weeks of treatment (at visit 2)', 'description': 'Occurrence of hyponatremia (plasma sodium \\<135 mmol/L)'}], 'secondaryOutcomes': [{'measure': 'Change in urinary Prostaglandin- concentration', 'timeFrame': 'Between baseline, visit 2 (and visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in urinary Prostaglandin E2 (PGE2) and metabolite (PGE2M)- concentration'}, {'measure': 'Change in the expression of proteins involved in sodium and water transport', 'timeFrame': 'Between baseline, visit 2 (and visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in the expression of proteins involved in sodium and water transport (AQP2, Prostaglandin transporter (PGT) and NCC) in urinary extracellular vesicles in spot urine (second morning urine)'}, {'measure': 'Change in systolic and diastolic blood pressure', 'timeFrame': 'Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in systolic and diastolic blood pressure'}, {'measure': 'Change in heart rate', 'timeFrame': 'Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in heart rate'}, {'measure': 'Change in body weight', 'timeFrame': 'Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in body weight'}, {'measure': 'Change in daily fluid intake', 'timeFrame': 'Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in daily fluid intake'}, {'measure': 'Change in Bioelectrical impedance analysis (BIA)', 'timeFrame': 'Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in Bioelectrical impedance analysis (BIA)'}, {'measure': 'Change in plasma sodium', 'timeFrame': 'Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks', 'description': 'Change in plasma sodium'}, {'measure': 'Change in urine sodium', 'timeFrame': 'Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks', 'description': 'Change in urine sodium'}, {'measure': 'Change in potassium', 'timeFrame': 'Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks', 'description': 'Change in potassium'}, {'measure': 'Change in chloride', 'timeFrame': 'Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks', 'description': 'Change in chloride'}, {'measure': 'Change in creatinine', 'timeFrame': 'Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks', 'description': 'Change in creatinine'}, {'measure': 'Change in urea', 'timeFrame': 'Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks', 'description': 'Change in urea'}, {'measure': 'Change in uric acid', 'timeFrame': 'Between baseline and visit 2 (and visit 2.1 if applicable), approximately 4 weeks', 'description': 'Change in uric acid'}, {'measure': 'Change in general well-being', 'timeFrame': 'Between baseline, visit 2 (visit 2.1 if applicable) and visit 3, approximately 3 months', 'description': 'Change in general well-being rated on a visual analogue scale reaching from 0 to 10'}, {'measure': 'Incidence of hyponatremia', 'timeFrame': 'Between baseline and visit 3, approximately 3 months', 'description': 'Incidence of hyponatremia'}, {'measure': 'Incidence of falls', 'timeFrame': 'Between baseline and visit 3, approximately 3 months', 'description': 'Incidence of falls'}, {'measure': 'Incidence of fractures', 'timeFrame': 'Between baseline and visit 3, approximately 3 months', 'description': 'Incidence of fractures'}, {'measure': 'Incidence of hospitalization due to any cause', 'timeFrame': 'Between baseline and visit 3, approximately 3 months', 'description': 'Incidence of hospitalization due to any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thiazide', 'Thiazide-like diuretics', 'Hyponatremia', 'Prostaglandin E2 (PGE2)', 'Urinary PGE2 concentration', 'Plasma sodium level', 'Urinary prostaglandins'], 'conditions': ['Thiazide-induced Hyponatremia (TIH)']}, 'descriptionModule': {'briefSummary': 'Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. This study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment.', 'detailedDescription': 'Thiazides and thiazide-like diuretics are one of the five major classes of antihypertensive drugs. They act by inhibiting the apical Na+-Cl- -cotransporter in the distal convoluted tubules of the kidneys. Thiazides and thiazide-like diuretics often cause adverse effects, importantly a drop in plasma sodium levels that is called thiazide-induced hyponatremia (TIH). Data suggest a crucial role of urinary PGE2 in water reabsorption. Since urinary PGE2 concentrations were higher in patients with TIH, quantification of urinary PGE2 prior and after thiazide initiation might allow identification of patients at risk for TIH, presenting PGE2 as a potential novel predictive marker for the development of TIH.\n\nThis study is to investigate whether urinary PGE2 concentration at baseline (prior to thiazide initiation) is associated with the development of TIH within the first four weeks of treatment. Hospitalized and ambulatory patients in whom a thiazide or thiazide-like diuretic will be newly prescribed are screened for inclusion.\n\nThe study procedure contains the screening and inclusion, visit 1 before thiazide initiation, visit 2 4 weeks (+/-7days) after thiazide initiation and a 3-months follow-up (visit 3). An additional visit (visit 2.1) will only be added in case of a dose change of the thiazide or thiazide-like diuretic (4 weeks +/- 7 days after the dose change). The 2 hours- challenge is optional if the patient agrees to additional testing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Hospitalized and ambulatory patients in whom a thiazide or thiazide-like diuretic will be newly prescribed. Screening will take place at the University Hospital Basel and Kantonsspital Baselland, primarily at the Endocrine Outpatient Clinic and the Hypertension Clinic of the Medical Outpatient Clinic or Nephrology Department and is based on the patients' charts as well as consultation with the treating physician.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly prescribed thiazide or thiazide-like diuretic\n* ≥ 18 years of age\n* Informed Consent as documented by signature\n\nExclusion Criteria:\n\n* Intake of thiazide or thiazide-like diuretic in the preceding month\n* Hyponatremia (plasma sodium \\<135 mmol/L) at baseline\n* Acute infectious / inflammatory disease (CRP ≥ 20 mg/L \\[1, 11\\])\n* Symptomatic urinary tract infection\n* Chronic treatment with NSAID and / or NSAID intake 48 hours prior to urine sampling at visit 1 and 2 (intake of acetylsalicylic acid will be no exclusion criteria)\n* End of life care, no informed consent or inability to follow the procedures of the study, e.g., due to language barriers, psychological disorders, dementia'}, 'identificationModule': {'nctId': 'NCT05542056', 'acronym': 'PROPHECY', 'briefTitle': 'Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Urinary Prostaglandin as a Potential Predictive Marker for Thiazide-induced Hyponatremia: a Prospective Cohort Study (The PROPHECY Study)', 'orgStudyIdInfo': {'id': '2022-01241; kt21ChristCrain3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with newly prescribed thiazide or thiazide-like diuretic', 'description': 'As the study population of this observational study shall be as representative as possible all patients with a new thiazide or thiazide-like diuretic regardless of the indication, co-morbidities and co-medication can be included.', 'interventionNames': ['Other: Data and biosample collection']}], 'interventions': [{'name': 'Data and biosample collection', 'type': 'OTHER', 'description': 'Collection of spot urine, blood sampling, vital parameters, body weight, medical history, patient questionnaires, drinking protocol, drug diary at at Visit 1 (before thiazide initiation), at Optional 2 hours-challenge, at Visit 2 (4 weeks after thiazide initiation), at Visit 2.1 (4 weeks after dose change), at Visit 3 (3-months after thiazide initiation)', 'armGroupLabels': ['Patients with newly prescribed thiazide or thiazide-like diuretic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28935', 'city': 'Móstoles', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alberto Fernandez Martinez, Prof. Dr. med.', 'role': 'CONTACT', 'email': 'afernamed@hotmail.com'}], 'facility': 'Hospital Universitario de Móstoles', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Julia Beck, Dr. med.', 'role': 'CONTACT', 'email': 'julia.beck@usb.ch', 'phone': '+41 61 328 54 37'}, {'name': 'Julia Beck, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sophie Monnerat', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thilo Burkard, Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Mayr, PD Dr. med.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ewout J. Hoorn, Prof. Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Basel, Endocrinology, Diabetes and Metabolism', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '4410', 'city': 'Liestal', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Felix Burkhalter Pirovino, Dr. med.', 'role': 'CONTACT'}, {'name': 'Felix Burkhalter Pirovino, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jörg Leuppi, Prof. Dr. med.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kantonsspital Baselland', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'centralContacts': [{'name': 'Julia Beck, Dr. med.', 'role': 'CONTACT', 'email': 'julia.beck@usb.ch', 'phone': '+41 61 328 54 37'}, {'name': 'Joyce Santos de Jesus', 'role': 'CONTACT', 'email': 'joyce.santosdejesus@usb.ch'}], 'overallOfficials': [{'name': 'Mirjam Christ-Crain, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel, Endocrinology, Diabetes and Metabolism'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}