Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 2:07 AM
Study NCT ID:
NCT01936350
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2013-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sildenafil Impact on Ventricular Function in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-06', 'studyFirstSubmitDate': '2013-09-02', 'studyFirstSubmitQcDate': '2013-09-02', 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement on ventricular function', 'timeFrame': 'one hour', 'description': 'Patients will undergo a cardiac magnetic resonance to evaluate ventricular function after one hour of sildenafil or placebo use'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart failure'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '25793988', 'type': 'DERIVED', 'citation': 'Fernandes AM, Andrade AC, Barroso ND, Borges IC, Carvalho-Andrade D, Rodrigues Junior ES, Guimaraes LC, Duraes AR, Borges SM, Aras Junior R. The immediate effect of sildenafil on right ventricular function in patients with heart failure measured by cardiac magnetic resonance: a randomized control trial. PLoS One. 2015 Mar 20;10(3):e0119623. doi: 10.1371/journal.pone.0119623. eCollection 2015.'}], 'seeAlsoLinks': [{'url': 'http://aplicacao.saude.gov.br/plataformabrasil/visao/pesquisador/gerirPesquisa/gerirPesquisa.jsf', 'label': 'approved by local Institutional Review Board'}]}, 'descriptionModule': {'briefSummary': 'Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or Sildenafil. After one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function.', 'detailedDescription': 'Twenty-four patients with known heart failure will be recruited. They will undergo a cardiac magnetic resonance for ventricular analyses and after this first exam they will be randomized to placebo or sildenafil. After one hour drug intake they will undergo another cardiac magnetic resonance to evaluate the drug impact on right and left ventricular function.\n\nThe first and second exams will be performed by the same staff. All patients will be evaluated by two, three and four chambers view. Left and right ventricle quantification analyses will be performed by Argus software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients with heart failure in stable clinical condition compatible with New York Heart Association functional class I to III. Eligibility criteria is consent to participate in the study after receiving detailed information about procedures, possible clinical benefits, and risks.\n\nExclusion Criteria: patients with new diagnosed lesions during the procedure, eg pulmonary mass and important claustrophobia, low blood pressure ( systolic blood pressure \\<90 mmHg or diastolic blood pressure \\<60 mmHg) nitrate or nebivolol use over the last 48 hours, metallic non MRI compatible implantable devices.'}, 'identificationModule': {'nctId': 'NCT01936350', 'briefTitle': 'Sildenafil Impact on Ventricular Function in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Ana Nery'}, 'officialTitle': 'Sildenafil Impact on Ventricular Function in Patients With Heart Failure: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '05378712.0.0000.0045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sildenafil', 'description': '12 patients will be in this group. They will take a sildenafil 50mg.', 'interventionNames': ['Drug: Sildenafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '12 patients will be in this group, they will take placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sildenafil', 'type': 'DRUG', 'description': 'The intervention in this group is the use of sildenafil 50mg; this group will take placebo and will be evaluated by cardiac magnetic resonance before and after the oral use of the drug.', 'armGroupLabels': ['Sildenafil']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo group'], 'description': 'This group will use placebo; this group will take placebo and will be evaluated by cardiac magnetic resonance before and after the oral use of the placebo pill.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40000', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital Ana Neri - MRI unit', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Andre M Fernandes, Master', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Ana Nery - Federal University of Bahia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Ana Nery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Andre Duraes, PhD', 'investigatorAffiliation': 'Hospital Ana Nery'}}}}