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 - RIVER II

Thoraxklinik Heidelberg gGmbH0 sites30 target enrollmentFebruary 25, 2021

ConditionsSymptomatic pulmonary arterial hypertension with a mean pulmonary artery pressure >20 mmHg and pulmonary vascular resistance =2 Wood Units, pulmonary arterial wedge pressure =15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension (PH)) or CTEPH (Group IV) with hemodynamics as stated above defined as inoperable measured at least 3 months after start of full anticoagulation or with persisting or recurrent PH after pulmonary endarterectomy at least 6 months after surgery MedDRA version: 20.0Level: HLTClassification code 10037401Term: Pulmonary hypertensionsSystem Organ Class: 100000004855 Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Symptomatic pulmonary arterial hypertension with a mean pulmonary artery pressure >20 mmHg and pulmonary vascular resistance =2 Wood Units, pulmonary arterial wedge pressure =15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension (PH)) or CTEPH (Group IV) with hemodynamics as stated above defined as inoperable measured at least 3 months after start of full anticoagulation or with persisting or recurrent PH after pulmonary endarterectomy at least 6 months after surgery
Sponsor: Thoraxklinik Heidelberg gGmbH
Enrollment: 30
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 25, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Thoraxklinik Heidelberg gGmbH

Eligibility Criteria

Inclusion Criteria

•1\.\=18 years of age at time of inclusion.
•2\.Male and female patients with symptomatic PAH with a mean pulmonary artery pressure (mPAP) \>20 mmHg and pulmonary vascular resistance (PVR) \=2 Wood Units (WU), pulmonary arterial wedge pressure (PAWP) \=15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension) or CTEPH (Group IV / Nice Clinical Classification of Pulmonary Hypertension) defined as inoperable measured at least 3 months after start of full anticoagulation and mPAP \>20 mmHg and PVR \=2 WU, PAWP \=15 mmHg; or with persisting or recurrent PH after pulmonary endarterectomy (mean pulmonary artery pressure \>20 mmHg and PVR \=2 WU, PAWP \=15 mmHg measured at least 6 months after surgery (acc. to Simonneau et al. 2018\).
•3\.Treatment naïve patients (with respect to PAH specific medication) and patients pre\-treated with an endothelin receptor antagonist or a prostacyclin analogue, pre\-treated for 2 months before screening at most (according to upfront combination treatment).\*
•4\.\*Pre\-treated patients need to be stable on endothelin receptor antagonists or prostacyclin treatment for at least two weeks prior to Visit 1\. Stable” is defined as no change in the type of endothelin receptor antagonists or prostacyclin analogue and the respective daily dose.
•5\.A patient may also be enrolled, if a persisting phosphodiesterase type 5 (PDE\-5\) inhibitor treatment (pre\-treated for 2 months before screening at most) with or without combination treatment with an endothelin receptor antagonist or prostacyclin analogue is to be switched to riociguat by clinical indication.
•6\.Unspecific treatments which may also be used for the treatment of PH such as oral anticoagulants, diuretics, digitalis, calcium channel blockers or oxygen supplementation are permitted. However, treatment with anticoagulants (if indicated) must have been started at least 1 month before visit 1\.
•7\.RHC results must not be older than 6 months at screening (will be considered as baseline values) and must have been measured in the participating centre under standardized conditions (refer to the study specific Swan Ganz catheterization manual). If the respective measurements have not been performed in context with the patient’s regular diagnostic workup, they have to be performed as a part of the study during the pre\-study phase (after the patient signed the informed consent).
•8\.Women without childbearing potential defined as postmenopausal women aged 50 years or older, women with bilateral tubal ligation, women with bilateral ovariectomy, and women with hysterectomy can be included in the study. Women with childbearing potential can only be included in the study if a serological pregnancy test is negative and a combination of condoms with a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain IUDs) is used.
•9\.Patients who are able to understand and follow instructions and who are able to participate in the study for the entire period.
•10\.Patients must have given their written informed consent to participate in the study after having received adequate previous information and prior to any study\-specific procedures.

Exclusion Criteria

•1\.Pregnant women, or breast\-feeding women, or women with childbearing potential not using a combination of condoms and a safe and highly effective contraception method (hormonal contraception with implants or combined oral contraceptives, certain IUDs).
•2\.Patients with PH specific treatment \>2 months before screening.
•3\.Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate or complete this study in the opinion of the investigator.
•4\.Patients with underlying medical disorders with an anticipated life expectancy below 2 years (e.g. active cancer disease with localized and/or metastasized tumour mass).
•5\.Patients with a history of severe allergies or multiple drug allergies.
•6\.Patients with hypersensitivity to the investigational drug or any of the excipients.
•7\.Patients unable to perform a valid 6MWD test (e.g. orthopaedic disease, peripheral artery occlusive disease, which affects the patient´s ability to walk).
•8\.The following specific medications for concomitant treatment of PH or medications which may exert a pharmacodynamic interaction with the study drug are not allowed:
•a)Parenteral prostacyclin analogues
•b)Specific (e.g. sildenafil or tadalafil) or unspecific phosphodiesterase inhibitors (e.g. dipyridamole, theophylline)