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

NCT04062565 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 1812168816
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline to 3 months

Secondary Outcomes (12)

• Change in pulmonary and cardiac pressures

  Baseline to 3 months

• Change in pulmonary blood flow

  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

Study Arms (1)

Experimental

EXPERIMENTAL

Treprostinil and Riociguat

Drug: Treprostinil Injectable Product; Drug: Riociguat Pill

Interventions

Treprostinil Injectable Product DRUG

Injection

Also known as: Remodulin

Experimental

Riociguat Pill DRUG

Tablet

Also known as: Adempas

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Estimated creatinine clearance \< 30 mL/min
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal.
• Hemoglobin \< 75% of the lower limit of the normal range.
• Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
• Pregnant or breast-feeding.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

treprostinil; riociguat

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Franz Rischard, DO

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerie Boss, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, University of Arizona Pulmonary Hypertension Program

Model Details: All participants will receive Treprostinil 2-3 times per day as tolerated. * Subsequently, participants will receive Riociguat at 0.5 mg taken orally three times a day. * Participants will receive the first dose inpatient prior to discharge. * Participants will continue on a 2 ng/kg/min increase every other day for one week. * Riociguat will subsequently be increased by 0.5 mg taken orally three times a day the following week as tolerated. * Increases in Treprostinil and Riociguat will then alternate weeks such that only one medication is changed per week.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: August 20, 2019
• Study Start: March 25, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

US (1)