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Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH

A Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810)

NCT04062565•University of Arizona

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine if there is a greater effect to patients with advanced pulmonary arterial hypertension (PAH) by using a combination of two drugs, Treprostinil and Riociquat versus Treprostinil alone

Detailed Description

The purpose of this study is to evaluate the combined effect of parenteral treprostinil (TRE) and riociguat (RIO) versus parenteral TRE alone on right ventricular (RV)-pulmonary artery (PA) interaction (RVPA coupling) and global RV function in patients with advanced pulmonary arterial hypertension (PAH).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•WHO Category I PAH
•Resting mPAP ≥ 25 mmHg with a wedge pressure of ≤ 15mmHg during right heart catheterization.
•Need for parenteral TRE as determined by the PH specialist caring for the patient

Exclusion Criteria

•Patients with a mean arterial pressure \<60, and/or requiring vasopressor support
•Patients whom expected device (i.e. ECMO, RVAD) assistance or early pulmonary transplantation (within 3 months) seems inevitable
•Patients with a left ventricular ejection fraction \<50% or clinical, echocardiographic, and/or catheterization data consistent with heart failure with preserved ejection fraction (HFpEF) and/or moderate-severe aortic or mitral valve abnormality
•Patients with severe restrictive lung disease (FVC\<70% predicted) and/or obstructive lung disease (FEV1 \<70% predicted and FEV1/FVC \<70%).
•Patients with a history of pulmonary embolism within the last three months or evidence of chronic pulmonary embolism.
•Patients with a known contraindication to right heart catheterization.
•Patients whom have received active or previous pulmonary vasoactive medication within the previous 12 weeks.
•PAH associated with significant venous or capillary involvement (PCWP \> 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
•Pulmonary Hypertension belonging to groups 2 to 5 of the WHO classification.
•Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
+15 more criteria

Locations (1)

University of Arizona

Tucson, Arizona, United States

Key Dates

Start Date

March 25, 2019

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

February 20, 2025

Enrollment

ESTIMATED participants

Conditions

Pulmonary Arterial Hypertension

Interventions

Treprostinil Injectable Product

DRUG

Riociguat Pill

DRUG

Contacts

Valerie Boss, MS

CONTACT

520-626-8305 vbloss@email.arizona.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH

Inclusion Criteria

Exclusion Criteria

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