Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04646902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-07
First Post:
2020-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kynurenine/Tryptophan Ratio in Hypertension Associated to Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kynurenine / Tryptophan ratio', 'timeFrame': 'Day 1 (visit 1)', 'description': 'Ratio between kynurenine and tryptophan concentrations'}], 'secondaryOutcomes': [{'measure': 'Concentrations of metabolites', 'timeFrame': 'Day 1 (visit 1)', 'description': 'The relevant metabolites and their concentration will be identified by Partial Least Square Discriminant Analysis (PLS-DA) applied to non-targeted metabolomics.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'obstructive sleep apnea', 'tryptophan', 'aryl hydrocarbon receptor'], 'conditions': ['Hypertension Secondary']}, 'descriptionModule': {'briefSummary': 'Obstructive Sleep Apnea (OSA) is an independent risk factor for hypertension (HTN) and the most common cause of resistant HTN. The mechanisms underlying OSA-associated HTN are not completely understood. This is crucial to find novel therapeutic targets of OSA-associated HTN. The Aryl Hydrocarbon Receptor (AHR) is a cytosolic transcription factor that has been linked with the pathogenesis of HTN.\n\nThis study aims to evaluate the role of endogenous ligands of AHR such as kynurenine in discriminating patients with OSA-associated HTN. For that aim, a case-control study will be performed in patients with and without hypertension exposed and not exposed to OSA. Kynurenine and other metabolites will be quantified in urine and serum samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include 4 groups of adults: healthy volunteers; normotensive OSA patients; hypertensive OSA patients; hypertensive non OSA patients.', 'healthyVolunteers': True, 'eligibilityCriteria': "CASES (subjects with hypertension with and without OSA)\n\nInclusion Criteria:\n\n* Adults ≥ 30 years old attending the outpatient clinics of the clinical sites.\n* Diagnosis of hypertension defined either as: a) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or b) in untreated patients: office systolic blood pressure values \\>= 140 mmHg and/ or diastolic blood pressure values \\>= 90 mmHg.\n* Able to understand and communicate effectively with study personnel.\n* Giving written informed consent to participate.\n\nExclusion Criteria:\n\n* Self-reported pregnancy or breastfeeding.\n* Patients on haemodialysis or peritoneal dialysis.\n* Chronic liver disease with Child-Pugh score B or higher.\n* Hypertension attributed to renal artery stenosis, primary hyperaldosteronism, pheochromocytoma, Cushing's syndrome, coarctation of aorta.\n* History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.\n* Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.\n* Pulmonary hypertension.\n* Current diagnosed oncological disease.\n* Patients with known chronic or acute infectious diseases.\n* Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study\n\nCONTROLS (individuals without hypertension with and without OSA) For each case, an age and gender-matched control will be selected.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Patients on haemodialysis or peritoneal dialysis.\n* Chronic liver disease with Child-Pugh score b or higher.\n* History of any OSA surgical treatment to the palatal and hypopharyngeal regions, notably uvulopalatopharyngoplasty surgery (UPPP), palatal radio frequency ablation, tonsillectomy, lingual tonsillectomy, partial glossectomy, tongue base radio frequency ablation, genioglossal advancement, hyoid suspension, maxillomandibular advancement surgery (MMA) and active use of hypoglossal nerve stimulator.\n* Patients with a good adherence to CPAP, defined as the use of CPAP for at least 4 hours/night on 70% of nights during the last 3 months.\n* Pulmonary hypertension.\n* Current diagnosed oncological disease.\n* Patients with known chronic or acute infectious diseases.\n* Patients with known chronic or acute infectious diseases.\n* Other current severe progressive or uncontrolled disease which in the judgement of the investigator renders the patient unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT04646902', 'acronym': 'KYNTOSA', 'briefTitle': 'Kynurenine/Tryptophan Ratio in Hypertension Associated to Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Nova de Lisboa'}, 'officialTitle': 'Relevance of the Ratio Kynurenine/Tryptophan to Characterize Hypertension Associated to Obstructive Sleep Apnea (KYNTOSA)', 'orgStudyIdInfo': {'id': 'Kyntosa_02_20200428'}, 'secondaryIdInfos': [{'id': 'PTDC/MED-TOX30418/2017', 'type': 'OTHER_GRANT', 'domain': 'Fundação para a Ciência e a Tecnologia'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HTN_OSA', 'description': 'Patients with hypertension\\* with obstructive sleep apnea\\*\\*\n\n\\* Hypertension will be defined as: i) use of antihypertensive drug(s) and stable dose for at least 2 weeks prior to inclusion; or ii) in untreated patients: office systolic blood pressure values \\>= 140 mmHg and/ or diastolic blood pressure values \\>= 90 mmHg.\n\n\\*\\* OSA will be defined with a polysomnography level 1, 2 or 3 performed within the previous twelve months with:\n\n* an apnea-hypopnea index \\> 5 events per hour (with more than 50% of obstructive events) associated with symptoms (associated sleepiness, fatigue, insomnia, snoring, subjective nocturnal respiratory disturbance or observed apnea) or medical/psychiatric disorder (hypertension, coronary artery disease, atrial fibrillation, congestive heart failure, stroke, diabetes, cognitive dysfunction, or mood disorder), OR\n* an apnea-hypopnea index \\> 15 events per hour, AND\n* no significant changes in health, medications, or lifestyle since the polysomnography.'}, {'label': 'HTN_NoOSA', 'description': 'Patients with hypertension without obstructive sleep apnea'}, {'label': 'NoHTN_OSA', 'description': 'Patients without hypertension with obstructive sleep apnea'}, {'label': 'NoHTN_NoOSA', 'description': 'Patients without hypertension without obstructive sleep apnea (healthy controls)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar de Lisboa Central', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar Lisboa Ocidental', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital Beatriz Ângelo', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital da Luz', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital Fernando Fonseca', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}], 'overallOfficials': [{'name': 'Maria E Monteiro, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade NOVA Lisboa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Nova de Lisboa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Hospitalar Lisboa Ocidental', 'class': 'OTHER_GOV'}, {'name': 'Centro Hospitalar de Lisboa Central', 'class': 'OTHER'}, {'name': 'Hospital Beatriz Ângelo', 'class': 'OTHER'}, {'name': 'Hospital Fernando Fonseca', 'class': 'UNKNOWN'}, {'name': 'Hospital da Luz, Portugal', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}