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Telemonitoring to Treat Group 2 Pulmonary Hypertension

NCT04882774 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-06-06

No results posted yet for this study

Summary

This study aims to decrease elevated pressure in the lungs of patients with pulmonary hypertension from left heart with elevated pulmonary vascular resistance by utilizing aggressive fluid management with ReDS Pro System and CardioMEMS device. Participants with persistently elevated pulmonary pressure at Week 16 will begin oral treprostinil in combination with the fluid management plan while those with improved pressures maintain their fluid management plan for an additional 16 weeks.

Conditions

  • Pulmonary Hypertension Due to Left Heart Disease

Interventions

DRUG

Treprostinil Diolamine

Oral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

    collaborator OTHER

  • Mardi Gomberg -Maitland MD, MSc

    lead OTHER

Principal Investigators

  • Mardi Gomberg-Maitland, MD · George Washington University

  • Raymond Benza, MD · Ohio State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2025-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

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 NCT04882774 on ClinicalTrials.gov