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Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension

NCT03835676 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-15

No results posted yet for this study

Summary

In a group of patients with PAH treated with treprostinil, the current study aims to investigate the effect of treatment on RV structure and function; and correlate changes in RV structure and function with: World Health Organisation (WHO) class, Six-minute walk test, Quality of life (QoL), and Pre-specified biomarkers (N-terminal B-type natriuretic peptide (NT-ProBNP), Tissue growth factor-B B-type natriuretic peptide BNP, and Profibrotic markers)

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Treprostinil

After inclusion and baseline measurements, patients will receive treprostinil in addition to background therapy for 24 months. Follow-up assessment will include: * Clinical, echocardiographic, laboratory assessments will be repeated at 1, 3, 6, 12, 18, and 24 month (or when there is clinical indication) * CMR will be performed at 6 monthly intervals for 2 years. * Peak power output at 6,12, 18 and 24 month * Right-side cardiac catheterization will be performed at 6, 12 , 18 and 24 months (or when there is clinical indication)

Sponsors & Collaborators

  • Magdi H. Yacoub

    lead OTHER

Principal Investigators

  • Magdi H Yacoub, OM FRS · Magdi Yacoub Heart Foundation - Aswan Heart Centre

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2025-06-01
Completion
2025-12-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03835676 on ClinicalTrials.gov