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)

University of Arizona1 site in 1 country20 target enrollmentMarch 25, 2019

ConditionsPulmonary Arterial Hypertension

InterventionsTreprostinil Injectable Product Riociguat Pill

DrugsTreprostinil Injectable Product Riociguat Pill

Overview

Phase: Phase 3
Intervention: Treprostinil Injectable Product
Conditions: Pulmonary Arterial Hypertension
Sponsor: University of Arizona
Enrollment: 20
Locations: 1
Primary Endpoint: Change in stroke volume/end systolic volume (SV/ESV)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 25, 2019

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Arizona

Responsible Party

Principal Investigator

Franz Rischard, DO

Director, University of Arizona Pulmonary Hypertension Program

University of Arizona

Eligibility Criteria

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.

Arms & Interventions

Experimental

Treprostinil and Riociguat

Intervention: Treprostinil Injectable Product

Experimental

Treprostinil and Riociguat

Intervention: Riociguat Pill

Outcomes

Primary Outcomes

Change in stroke volume/end systolic volume (SV/ESV)

Time Frame: Baseline to 3 months

Change in stroke volume/end systolic volume (SV/ESV)

Secondary Outcomes

Change in Cardio pulmonary Exercise Testing (CPET)(3 months)
Change in pulmonary and cardiac pressures(Baseline to 3 months)
Change in pulmonary blood flow(Baseline to 3 months)
Change in derived VO2 max(3 months)
Change in derived Ve/VCO2(3 months)
Change in adverse event profile(Baseline to 3 months)
Change in end-systolic elastance/arterial elastance (Ees/Ea)(Baseline to 3 months)
Change in Right Ventricle (RV) diastolic stiffness (Beta)(Baseline to 3 months)
Change in 6 minute walk distance(Baseline to 3 months)
Change in brain natriuretic peptide (BNP)(Baseline to 3 months)
Change in magnetic resonance imaging (MRI) right ventricle volumes(Baseline to 3 months)
Change in composite time to clinical worsening(Baseline to 3 months)