Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2025-12-27 @ 6:32 AM
Study NCT ID:
NCT01800292
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2013-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2013-02-22', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'World Health Organization functional class', 'timeFrame': '3 months', 'description': 'World Health Organization functional class (I-IV) will be determined at baseline and at 3 months'}, {'measure': 'BNP (brain natriuretic peptide)', 'timeFrame': '3 months', 'description': 'Blood will be collected to get BNP (brain natriuretic peptide)lab result at baseline and at 3 months'}], 'primaryOutcomes': [{'measure': 'exercise capacity not on/on sildenafil therapy', 'timeFrame': '3 months', 'description': 'Subjects will have 6 minute walk testing prior to sildenafil therapy and 3 months post-initiation of sildenafil therapy. Improvement in submaximal exercise capacity on sildenafil therapy is defined as ≥ 30 M increase in 6 minute walk testing.'}], 'secondaryOutcomes': [{'measure': 'Echo parameters:left ventricular septal and lateral wall longitudinal strain and strain rate, RV strain and strain rate, and LV lateral wall/septal strain and strain rate', 'timeFrame': '3 months', 'description': 'Echo parameters will be collected pre-therapy vs 3 months on sildenafil therapy. Changes in ventricular wall motion will be documented with left ventricular (LV) septal and lateral wall longitudinal strain and strain rate, right ventricular strain and strain rate, and LV lateral wall/septal strain and strain rate utilizing speckle tracking techniques values determined by 2D-Echo.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Artery Hypertension', 'pulmonary capillary wedge pressure', 'sildenafil', 'echocardiography', 'left ventricular longitudinal wall strain', 'strain rate pre and post medical therapy', 'speckle tracking'], 'conditions': ['Hypertension, Pulmonary Artery', 'Ventricular Dysfunction, Left']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if patients with pulmonary hypertension and mildly elevated heart pressure known as PCWP will exhibit different patterns on echocardiography and that these patterns will predict treatment response to sildenafil, a drug given for this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with New York Heart Association/World Health Organization(NYHA/WHO)functional class II-III\n* Patients with mean pulmonary artery pressure \\>25 mmHg, pulmonary capillary wedge pressure \\>15 mmHg ≤18, and pulmonary vascular resistance \\>3 wood units\n* Age \\>18 and \\<80\n* Stable on antihypertensives and diuretics\\>3 months\n* No evidence of active ischemic heart disease\n* 6 minute walk distance \\>150 meters and \\<450 meters\n\nExclusion Criteria:\n\n* \\- Left ventricular ejection fraction \\<50%\n* Patients with significant restrictive lung disease (FVC\\<60% predicted) and/or significant obstructive lung disease (FEV1 \\<55% predicted) within 1 year of enrollment\n* Poorly interpretable grey scale echocardiographic images\n* Contraindications to right heart catheterization\n* Nitroglycerin therapy\n* Moderate-severe aortic and mitral valve abnormality\n* Contraindications to submaximal exercise testing'}, 'identificationModule': {'nctId': 'NCT01800292', 'acronym': 'LV strain', 'briefTitle': 'Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH.', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Echo Study - Characterization of LV Strain Patterns in Patients With Mildly Elevated PCWP and Pulmonary Hypertension', 'orgStudyIdInfo': {'id': '13-0006-01'}, 'secondaryIdInfos': [{'id': '986-12', 'type': 'OTHER', 'domain': 'University Medical Center Site Review Authority'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sildenafil therapy', 'description': 'Subjects will have 2D-Echocardiogram measuring left ventricular strain and strain rate using speckle tracking techniques, have 6 minute walk test, World Health Organization functional class (I-IV)assignment, and BNP lab result at baseline and at 3 months. Subjects will be started on sildenafil at 20 mg by mouth three times per day at the baseline visit. Each individual will serve as his/her own control.', 'interventionNames': ['Drug: sildenafil']}], 'interventions': [{'name': 'sildenafil', 'type': 'DRUG', 'otherNames': ['Revatio', 'compound UK-92,480', 'Patent 5,250,534', 'sildenafil citrate', 'NDA 22-473', 'C22H30N6O4S.C6H8O7', 'C28H38N6O11S'], 'description': 'Subjects will be started on sildenafil at 20 mg PO TID at the baseline visit. Each individual will serve as his/her own control. Subjects will be evaluated at 3 months, with participation completed at that time.', 'armGroupLabels': ['sildenafil therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Aiden Abidov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Medicine and Radiology', 'investigatorFullName': 'Aiden Abidov', 'investigatorAffiliation': 'University of Arizona'}}}}