NCT03809156

Upfront Combination Pulmonary Arterial Hypertension Therapy

Upfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of first-line combination therapy using riociguat with ambrisentan in patients with Pulmonary Arterial Hypertension (PAH).

Detailed description

This is a prospective, multi-center, open-label, exploratory study with patients followed for a period of one year. The treatment duration period in this study begins at the initiation of ambrisentan plus riociguat and will continue for 12 months. Patients will come to clinic for a visit at month 4 and 12. Assessments will include Right Heart Catheterization, 6 Minute walk test, cardiac MRI, questionnaires and nt-Pro-BNP.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Riociguat Oral Product	Dual therapy of Riociguat and Ambrisentan at initiation of treatment.

Timeline

• Start date: 2016-04-26
• Primary completion: 2020-12-31
• Completion: 2021-01-31
• First posted: 2019-01-18
• Last updated: 2020-03-26

Locations

2 sites across 1 country: Canada