Ignite Creation Date:
2024-05-06 @ 4:20 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04954742
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2021-06-29
Brief Title:
Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
An Open-label Prospective Single Centre Study of the Effects of Riociguat on RIght VEntricular Size and Function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2024-03
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:
RIVERII
Brief Summary:
This is an open-label single-armed prospective single-centre clinical study to evaluate the effect of riociguat on right heart size and function in patients with manifest PAH and CTEPH
Detailed Description:
Right heart size and function are of utmost prognostic importance in PAHCTEPH RV performance measured by echocardiography and enlarged RA area have been shown to be independent prognostic factors in PAH Recently a retrospective single centre study has shown that riociguat treatment was associated with a significant reduction of RV and RA area after 3 6 and 12 months compared to baseline RA area significantly decreased after 12 months and RV systolic function assessed with tricuspid annular plane systolic excursion TAPSE improved after 6 and 12 months of riociguat therapy The results were confirmed by a recent retrospective multicentre study It is therefore reasonable to assume a beneficial effect of riociguat on right heart size and function
The primary efficacy endpoint in this study is the change in RV and RA area from baseline to 24 weeks Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability Patients who discontinue medication prematurely will be asked to continue with study assessments and perform study visits as outlined in the protocol
Medical examinations comprise medical history physical examination electrocardiogram ECG blood gas analyses lung function tests laboratory testing including NT-proBNP echocardiography at rest and right heart catheterization RHC according to clinical practice of the PH centre
The prospective period of data collection comprises a 24-week study period a follow-up phase of about 307 days
Outcome survival and transplant-free survival of all patients will be assessed when the last patient has terminated hisher 24-week observation period
The primary efficacy endpoint in this study is the change in RV and RA area from baseline to 24 weeks Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability Patients who discontinue medication prematurely will be asked to continue with study assessments and perform study visits as outlined in the protocol
Medical examinations comprise medical history physical examination electrocardiogram ECG blood gas analyses lung function tests laboratory testing including NT-proBNP echocardiography at rest and right heart catheterization RHC according to clinical practice of the PH centre
The prospective period of data collection comprises a 24-week study period a follow-up phase of about 307 days
Outcome survival and transplant-free survival of all patients will be assessed when the last patient has terminated hisher 24-week observation period
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?:
False
Is an FDA AA801 Violation?:
None