Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Adverse event data will be covered in Adverse events section.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Experimental | Participants received a single oral dose of 1 mg riociguat. |
|
| Placebo | Placebo Comparator | Participants received a single oral dose of 1 mg placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Drug | 1 mg single oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Power Index at Rest | 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 | Before and 1 hour after administration of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular Stroke Work Index (LVSWI) at Rest | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | 02114-2696 | United States | |||
One subject was screened, randomized and treated during this study. The subject completed the study according to protocol.
Only subjects symptomatic with pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD) could participate in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Riociguat (Adempas, BAY63-2521) | Participants received a single oral dose of 1 mg riociguat. |
| FG001 | Placebo | Participants received a single oral dose of 1 mg placebo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Single oral dose |
|
| Before and 1 hour after administration of study drug |
| Change in Left Ventricular Ejection Fraction (LVEF) at Rest | 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 | Before and 1 hour after administration of study drug |
| Change in End-systolic Elastance at Rest | 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 | Before and 1 hour after administration of study drug |
| Change in Peak Power Index During the Cardiopulmonary Exercise Tests | 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 | Before and 1 hour after administration of study drug |
| Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests | The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Before and 1 hour after administration of study drug |
| Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests | The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Before and 1 hour after administration of study drug |
| Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests | The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Before and 1 hour after administration of study drug |
| Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E') During the Cardiopulmonary Exercise Tests | The lateral mitral annular peak early diastolic velocity (E') is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Before and 1 hour after administration of study drug |
| Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests | 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. | Before and 1 hour after administration of study drug |
| Change in the Ventilatory Efficiency (V'E/V'CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET) | 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. | Before and 1 hour after administration of study drug |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Riociguat (Adempas, BAY63-2521) | Participants received a single oral dose of 1 mg riociguat. |
| BG001 | Placebo | Participants received a single oral dose of 1 mg placebo. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| |||||||||||||||||||||||
| Gender | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Peak Power Index at Rest | 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 | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in Left Ventricular Stroke Work Index (LVSWI) at Rest | 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 | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in Left Ventricular Ejection Fraction (LVEF) at Rest | 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 | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in End-systolic Elastance at Rest | 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 | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in Peak Power Index During the Cardiopulmonary Exercise Tests | 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 | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in Lateral Mitral Annular Peak Systolic Velocity (Sm) During the Cardiopulmonary Exercise Tests | The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in Peak Systolic Tricuspid Annular Velocity (RV-Sm) During the Cardiopulmonary Exercise Tests | The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) During the Cardiopulmonary Exercise Tests | The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in Lateral Mitral Annular Peak Early Diastolic Velocity (E') During the Cardiopulmonary Exercise Tests | The lateral mitral annular peak early diastolic velocity (E') is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination. | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in the Slope of the Relationship Between Work Rate and Mean Pulmonary Arterial Pressure (PAPmean) During the Cardiopulmonary Exercise Tests | 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. | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
| ||||||||||||||||||||||
| Secondary | Change in the Ventilatory Efficiency (V'E/V'CO2) Measured From Baseline to the Anaerobic Threshold (AT) During the Cardiopulmonary Exercise Tests (CPET) | 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. | Due to the very low number of patients enrolled in the study, no statistical evaluation was done. | Posted | Before and 1 hour after administration of study drug |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Riociguat (Adempas, BAY63-2521) | Participants received a single oral dose of 1 mg riociguat. | 0 | 1 | 0 | 1 | ||
| EG001 | Placebo | Participants received a single oral dose of 1 mg placebo. | 0 | 0 | 0 | 0 |
Not provided
Not provided
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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542595 | riociguat |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|