Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-30 @ 7:57 PM
Study NCT ID:
NCT01065051
Status:
TERMINATED
Last Update Posted:
2014-01-06
First Post:
2010-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542595', 'term': 'riociguat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'otherDetails': 'The Investigative Site, Institution and/or Principal Investigator shall furnish the Sponsor with a copy of any proposed publication of material described in Clinical Trial Agreement at least sixty (60) days in advance of the date of submission for publication or presentation. Within sixty (60) day period, the Sponsor shall: review such proposed publication for any patentable subject matter or designated Confidential Information, which the Sponsor may have furnished to facilitate the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated prematurely due to low recruitment (one subject enrolled only). No statistical analyses of efficacy parameters were performed. Therefore, no clinically meaningful conclusions can be drawn from the data generated.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Peak Power Index at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)\\*CO \\[cardiac output\\]\\*16.667/LVEDV', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Stroke Work Index (LVSWI) at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The left ventricular stroke work index (LVSWI) is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The LVSWI is also dependent of the calculated hemodynamic parameter stroke volume index (SVI). Formula: LVSWI = (SAPmean - PCWPmean)\\*SVI\\*0.0136', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Ejection Fraction (LVEF) at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100\\*(LVEDV - LVESV)/LVEDV', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in End-systolic Elastance at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The end-systolic elastance is a calculated hemodynamic parameter. It is approximated by the directly measured hemodynamic parameter end-systolic pressure divided by the directly measured echocardiography parameter left ventricular end-systolic volume (LVESV). The end-systolic pressure is acquired during a right heart catheterization. The LVESV is acquired during a non-invasive echocardiography examination. Approximated by end-systolic pressure/LVESV', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in Peak Power Index During the Cardiopulmonary Exercise Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. Formula: Peak Power Index = (SAPmean - PCWPmean)\\*CO\\*16.667/LVEDV', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': "Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E') During the Cardiopulmonary Exercise Tests", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': "The lateral mitral annular peak early diastolic velocity (E') is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': 'Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The slope of the relationship between work rate during cardiopulmonary exercise tests and PAPmean is derived from the directly measured hemodynamic parameter mean pulmonary arterial pressure (PAPmean). PAPmean is acquired during a right heart catheterization.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}, {'type': 'SECONDARY', 'title': "Change in the Ventilatory Efficiency (V'E/V'CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': "Ventilatory efficiency (V'E/V'CO2) and anaerobic threshold (AT) were parameters directly measured or derived by computed analysis from the spiroergometry system during the cardiopulmonary exercise test.", 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the very low number of patients enrolled in the study, no statistical evaluation was done.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Only subjects symptomatic with pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD) could participate in this study.', 'preAssignmentDetails': 'One subject was screened, randomized and treated during this study. The subject completed the study according to protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-31', 'studyFirstSubmitDate': '2010-02-08', 'resultsFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2010-02-08', 'lastUpdatePostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-31', 'studyFirstPostDateStruct': {'date': '2010-02-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Peak Power Index at Rest', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The peak power index is calculated from the maximal power (which also takes the calculated parameter cardiac output into account) divided by the left ventricular end-diastolic volume (LVEDV). Formula: Peak Power Index = (SAPmean - PCWPmean)\\*CO \\[cardiac output\\]\\*16.667/LVEDV'}], 'secondaryOutcomes': [{'measure': 'Change in Left Ventricular Stroke Work Index (LVSWI) at Rest', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The left ventricular stroke work index (LVSWI) is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. The LVSWI is also dependent of the calculated hemodynamic parameter stroke volume index (SVI). Formula: LVSWI = (SAPmean - PCWPmean)\\*SVI\\*0.0136'}, {'measure': 'Change in Left Ventricular Ejection Fraction (LVEF) at Rest', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The left ventricular ejection fraction work index (LVEF) is a calculated echocardiography parameter. LVEF is derived from the directly measured parameters left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV). These 2 parameters are acquired during a non-invasive echocardiography examination. Formula: LEVF = 100\\*(LVEDV - LVESV)/LVEDV'}, {'measure': 'Change in End-systolic Elastance at Rest', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The end-systolic elastance is a calculated hemodynamic parameter. It is approximated by the directly measured hemodynamic parameter end-systolic pressure divided by the directly measured echocardiography parameter left ventricular end-systolic volume (LVESV). The end-systolic pressure is acquired during a right heart catheterization. The LVESV is acquired during a non-invasive echocardiography examination. Approximated by end-systolic pressure/LVESV'}, {'measure': 'Change in Peak Power Index During the Cardiopulmonary Exercise Tests', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The peak power index is a calculated hemodynamic parameter. It is derived from the directly measured parameters mean systolic arterial pressure (SAPmean) and mean pulmonary capillary wedge pressure (PCWPmean). These 2 parameters are acquired during a right heart catheterization. Formula: Peak Power Index = (SAPmean - PCWPmean)\\*CO\\*16.667/LVEDV'}, {'measure': 'Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.'}, {'measure': 'Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.'}, {'measure': 'Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.'}, {'measure': "Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E') During the Cardiopulmonary Exercise Tests", 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': "The lateral mitral annular peak early diastolic velocity (E') is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination."}, {'measure': 'Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests', 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': 'The slope of the relationship between work rate during cardiopulmonary exercise tests and PAPmean is derived from the directly measured hemodynamic parameter mean pulmonary arterial pressure (PAPmean). PAPmean is acquired during a right heart catheterization.'}, {'measure': "Change in the Ventilatory Efficiency (V'E/V'CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET)", 'timeFrame': 'Before and 1 hour after administration of study drug', 'description': "Ventilatory efficiency (V'E/V'CO2) and anaerobic threshold (AT) were parameters directly measured or derived by computed analysis from the spiroergometry system during the cardiopulmonary exercise test."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Left ventricular dysfunction'], 'conditions': ['Hypertension, Pulmonary', 'Ventricular Dysfunction, Left']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction', 'detailedDescription': 'Adverse event data will be covered in Adverse events section.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy\n\nExclusion Criteria:\n\n* Types of pulmonary hypertension other than group 2.1 of Dana Point Classification'}, 'identificationModule': {'nctId': 'NCT01065051', 'acronym': 'HEARTWORK', 'briefTitle': 'Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Effects of a Single Dose of 1 mg Riociguat (BAY63-2521) on Myocardial Contractility and Relaxation in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction (PH-sLVD)', 'orgStudyIdInfo': {'id': '14549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Riociguat (Adempas, BAY63-2521)', 'description': 'Participants received a single oral dose of 1 mg riociguat.', 'interventionNames': ['Drug: Riociguat (Adempas, BAY63-2521)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received a single oral dose of 1 mg placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Riociguat (Adempas, BAY63-2521)', 'type': 'DRUG', 'description': '1 mg single oral dose', 'armGroupLabels': ['Riociguat (Adempas, BAY63-2521)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114-2696', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}