Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:20 PM
Study NCT ID:
NCT00361127
Status:
COMPLETED
Last Update Posted:
2016-01-28
First Post:
2006-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D011654', 'term': 'Pulmonary Edema'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-27', 'studyFirstSubmitDate': '2006-08-04', 'studyFirstSubmitQcDate': '2006-08-04', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure', 'timeFrame': 'Third day'}], 'secondaryOutcomes': [{'measure': 'Influence of ACE-genotype on exercise capacity', 'timeFrame': 'Third day'}, {'measure': 'Influence of ACE-genotype on lung function', 'timeFrame': 'Third day'}]}, 'conditionsModule': {'keywords': ['Heart failure', 'pulmonary edema', 'ACE-inhibitors', 'lung diffusion', 'exercise capacity', 'Chronic heart failure'], 'conditions': ['Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '14581402', 'type': 'BACKGROUND', 'citation': 'Agostoni P, Cattadori G, Bianchi M, Wasserman K. Exercise-induced pulmonary edema in heart failure. Circulation. 2003 Nov 25;108(21):2666-71. doi: 10.1161/01.CIR.0000097115.61309.59. Epub 2003 Oct 27.'}, {'pmid': '9107182', 'type': 'BACKGROUND', 'citation': 'Guazzi M, Marenzi G, Alimento M, Contini M, Agostoni P. Improvement of alveolar-capillary membrane diffusing capacity with enalapril in chronic heart failure and counteracting effect of aspirin. Circulation. 1997 Apr 1;95(7):1930-6. doi: 10.1161/01.cir.95.7.1930.'}]}, 'descriptionModule': {'briefSummary': 'In patients with chronic heart failure ACE-inhibitor treatment improves lung diffusion and prevents pulmonary edema after fluid overload. In the western country, 3 population types of ACE genotypes exist (DD, ID, II). It is unknown whether the ACE genotype influences the response to fluid overload in ACE-inhibitor treated chronic heart failure patients.', 'detailedDescription': 'Patients with chronic heart failure in stable clinical condition treated with ACE-inhibitors, but not aspirin, will be evaluated by means of maximal cardiopulmonary exercise test and lung function including lung diffusion measurements. These tests will be done before and after rapid 500 ml isotonic saline infusion. Patients will be grouped according to their ACE genotype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New York Heart Association (NYHA) class I and II heart failure\n* Chronic ACE-inhibitor treatment\n\nExclusion Criteria:\n\n* Aspirin treatment in the previous 2 months'}, 'identificationModule': {'nctId': 'NCT00361127', 'briefTitle': 'Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Centro Cardiologico Monzino'}, 'officialTitle': 'Influence of ACE Genotype on Lung Diffusion at Rest and After Fluid Overload in Heart Failure Patients Treated With ACE-inhibitors', 'orgStudyIdInfo': {'id': 'CCM S65/206'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CMPD patients', 'description': 'Patients with CMPD with evaluation of ACE I/D polymorphism', 'interventionNames': ['Drug: isotonic saline infusion']}], 'interventions': [{'name': 'isotonic saline infusion', 'type': 'DRUG', 'armGroupLabels': ['CMPD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Piergiuseppe Agostoni, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro Cardiologico Monzino'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Piergiuseppe Agostoni', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Piergiuseppe Agostoni', 'investigatorAffiliation': 'Centro Cardiologico Monzino'}}}}