Trial Outcomes & Findings for Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics (NCT NCT01065051)

NCT ID: NCT01065051

Last Updated: 2014-01-06

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Before and 1 hour after administration of study drug
• Results posted on: 2014-01-06

Participant Flow

Only subjects symptomatic with pulmonary hypertension associated with left ventricular systolic dysfunction (PH-sLVD) could participate in this study.

One subject was screened, randomized and treated during this study. The subject completed the study according to protocol.

Participant milestones

Measure	Riociguat (Adempas, BAY63-2521) Participants received a single oral dose of 1 mg riociguat.	Placebo Participants received a single oral dose of 1 mg placebo.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics

Baseline characteristics by cohort

Measure	Riociguat (Adempas, BAY63-2521) n=1 Participants Participants received a single oral dose of 1 mg riociguat.	Placebo Participants received a single oral dose of 1 mg placebo.	Total n=1 Participants Total of all reporting groups
Age, Customized <65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Customized >=65 years	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Gender Female	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

The lateral mitral annular peak systolic velocity (Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

The peak systolic tricuspid annular velocity (RV-Sm) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

The tricuspid annular plane systolic excursion (TAPSE) is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

The lateral mitral annular peak early diastolic velocity (E') is a measured echocardiography parameter. It is acquired during a non-invasive echocardiography examination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before and 1 hour after administration of study drug

Population: Due to the very low number of patients enrolled in the study, no statistical evaluation was done.

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.

Outcome measures

Outcome data not reported

Adverse Events

Riociguat (Adempas, BAY63-2521)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area Head

BAYER

Email: clinical-trials-contact@bayerhealthcare.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER