Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05339087
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2022-04-14
Brief Title:
Efficacy and Safety of Riociguat in Incipient Pulmonary Vascular Disease as an Indicator for Early PAH
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Efficacy and Safety of Riociguat MK-4836 in Incipient Pulmonary Vascular Disease as an Indicator for Early Pulmonary Arterial Hypertension Double-blind Randomized Multicenter Multinational Placebo-controlled Phase IIa Study ESRA
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESRA
Brief Summary:
This is a randomized double-blind placebo-controlled multicenter multinational study investigating the effect of riociguat MK-4836 in patients with early pulmonary vascular disease
Detailed Description:
Chronic pulmonary arterial hypertension PAH is associated with impaired exercise capacity quality of life and right ventricular function characterized by an increase of pulmonary vascular resistance PVR and pulmonary arterial pressure leading to right heart insufficiency
Riociguat tratment is approved for both PAH and chronic thromboembolic pulmonary hypertension CTEPH
Data on early treatment of patients with mildly elevated pulmonary arterial pressures is still scarce but there is evindence that such patients may benefit from early targeted therapy
For instance in a trial on systemic sclerosis SSc-patients with mildly elevated mean pulmonary artery pressure mPAP andor exercise pulmonary hypertension without significant left heart or lung disease ambrisentan an endothelin receptor antagonist resulted in an improvement of PVR as secondary endpoint which may be of prognostic relevance in this patient cohort and requires further research
Besides its prognostic significance among patients with SSc-APAH PVR may be an indicator of early pulmonary vascular disease and previous studies proved the positive effects of riociguat on right heart size and PVR secondary endpoint in phase III studies Thus PVR was chosen as primary endpoint of this study aiming to investigate the effect of riociguat MK-4836 on PVR clinical parameters safety and tolerability in patients with early pulmonary vascular disease
Eligible subjects will be randomized in a 11 ratio to receive either riociguat or placebo
Medical examinations include medical history physical examination electrocardiogram blood gas analyses lung function tests laboratory testing including NT-proBNP echocardiography at rest and right heart catheterization
The prospective period of data collection comprises a 24-week treatment phase diveded into an 8-week titration phase followed by a 16-week main study phase as well as a safety follow-up of 3014 days
Riociguat tratment is approved for both PAH and chronic thromboembolic pulmonary hypertension CTEPH
Data on early treatment of patients with mildly elevated pulmonary arterial pressures is still scarce but there is evindence that such patients may benefit from early targeted therapy
For instance in a trial on systemic sclerosis SSc-patients with mildly elevated mean pulmonary artery pressure mPAP andor exercise pulmonary hypertension without significant left heart or lung disease ambrisentan an endothelin receptor antagonist resulted in an improvement of PVR as secondary endpoint which may be of prognostic relevance in this patient cohort and requires further research
Besides its prognostic significance among patients with SSc-APAH PVR may be an indicator of early pulmonary vascular disease and previous studies proved the positive effects of riociguat on right heart size and PVR secondary endpoint in phase III studies Thus PVR was chosen as primary endpoint of this study aiming to investigate the effect of riociguat MK-4836 on PVR clinical parameters safety and tolerability in patients with early pulmonary vascular disease
Eligible subjects will be randomized in a 11 ratio to receive either riociguat or placebo
Medical examinations include medical history physical examination electrocardiogram blood gas analyses lung function tests laboratory testing including NT-proBNP echocardiography at rest and right heart catheterization
The prospective period of data collection comprises a 24-week treatment phase diveded into an 8-week titration phase followed by a 16-week main study phase as well as a safety follow-up of 3014 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None