NCT03362047

(RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment)

Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Giessen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Pilot study to determine the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan, evaluated by the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.

Detailed description

In this multi-center, randomized, open pilot study the therapeutic effect of two prarallel groups treated with either Riciguat or Macitentan shall be determined by evaluating the change in systolic and diastolic RV function within 12 weeks after first drug intake in order to plan a larger Phase II study.The method used to determine the RV function will be the "Conductance Method".

Conditions

• Pulmonary Arterial Hypertension (PAH)

Interventions

Type	Name	Description
DRUG	Riciguat Group	Patients will be administered 12 weeks Riciguat
DRUG	Macitentan Group	Patients will be administered 12 weeks Macitentan

Timeline

• Start date: 2018-03-01
• Primary completion: 2024-07-03
• Completion: 2024-08-14
• First posted: 2017-12-05
• Last updated: 2025-03-30

Locations

3 sites across 1 country: Germany