Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 4:54 PM
Study NCT ID:
NCT01896661
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2013-07-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Antihypertensive Agents Over Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D002752', 'term': 'Chlorthalidone'}, {'id': 'D000584', 'term': 'Amiloride'}, {'id': 'D002121', 'term': 'Calcium Channel Blockers'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D045283', 'term': 'Natriuretic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D000077264', 'term': 'Calcium-Regulating Hormones and Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2013-07-10', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea-Hypopnea Index', 'timeFrame': '8 weeks', 'description': 'Number of apneas/hour'}, {'measure': 'Blood Pressure', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '8 weeks'}, {'measure': 'Somnolence scale (Epworth) and ventilatory parameters', 'timeFrame': '8 weeks'}, {'measure': 'C reactive protein', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep apnea', 'Hypertension', 'Treatment', 'Diuretics', 'Chlorthalidone', 'Amlodipine'], 'conditions': ['Hypertension', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '38781664', 'type': 'DERIVED', 'citation': 'Cichelero FT, Fuchs SC, Jorge JA, Martinez D, Oliveira GPF, Lucca MB, Oliveira ACT, Fuchs FD. Effect of antihypertensive agents on sleep apnea and ambulatory blood pressure in patients with hypertension: A randomized controlled trial. Sleep Med. 2024 Jul;119:417-423. doi: 10.1016/j.sleep.2024.05.035. Epub 2024 May 16.'}, {'pmid': '24382030', 'type': 'DERIVED', 'citation': 'Cichelero FT, Martinez D, Fuchs SC, Gus M, Moreira LB, Fuchs FD. The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial. Trials. 2014 Jan 2;15:1. doi: 10.1186/1745-6215-15-1.'}]}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. There are several drugs to control hypertension, but the only consistently beneficial treatment to reduce apneas is continuous positive airway pressure. The demonstration that one drug could improve sleep apnea and hypertension would support a novel approach in the treatment of both diseases. The role of fluid retention in sleep apnea is known for several decades. The role of diuretics is well established in hypertension but was never appropriately tested in sleep apnea. Besides to test the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and its treatment.', 'detailedDescription': 'This is a randomized, double-blind, clinical trial, comparing the association of Chlorthalidone plus amiloride 25 and 5 mg daily, versus amlodipine 10 mg daily as first drug option in patients older than 40 years of age with Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (15-30 apneas/hour of sleep). The primary outcomes will be the variation of apneas/hour and blood pressure. The secondary outcomes will be adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein. The follow up will last 8 weeks. The sample size will be of 29 participants per group. The project was approved by the Ethics committee of our institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 40 years of age\n* Stage I hypertension (140-159/90-99 mmHg) and moderate obstructive sleep apnea (10-40 apneas/hour of sleep)\n\nExclusion Criteria:\n\n* Low life expectancy\n* Other indications for the use of diuretics or calcium channel blocker -Intolerance or contraindications to the study drugs\n* Pregnancy\n* Established cardiovascular disease (myocardial infarction\n* Stroke\n* Heart failure)\n* Use of more than one drug for hypertension\n* Secondary hypertension\n* Participation in other clinical trial in previous 6 months'}, 'identificationModule': {'nctId': 'NCT01896661', 'briefTitle': 'Effect of Antihypertensive Agents Over Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'The Effect of Antihypertensive Agents Over Sleep Apnea: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '07572112.7.0000.5327'}, 'secondaryIdInfos': [{'id': '12-0417', 'type': 'OTHER', 'domain': 'WebGPPG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diuretics', 'description': 'Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning', 'interventionNames': ['Drug: Diuretics']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Calcium Channel Blockers', 'description': 'Amlodipine 10 mg daily, taking in the morning', 'interventionNames': ['Drug: Calcium Channel Blockers']}], 'interventions': [{'name': 'Diuretics', 'type': 'DRUG', 'otherNames': ['Chlorthalidone/Amiloride'], 'description': 'Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning', 'armGroupLabels': ['Diuretics']}, {'name': 'Calcium Channel Blockers', 'type': 'DRUG', 'otherNames': ['Amlodipine'], 'description': 'Amlodipine 10 mg daily, taking in the morning', 'armGroupLabels': ['Calcium Channel Blockers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clinicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Flavio D Fuchs, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul'}, {'name': 'Fabio T Cichelero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Rio Grande do Sul'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}