NCT04882774

Telemonitoring to Treat Group 2 Pulmonary Hypertension

Telemonitoring to Treat Group 2 Pulmonary Hypertension: A Personalized Approach

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mardi Gomberg -Maitland MD, MSc · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study hypothesizes that monitoring with ReDS-Pro System (ReDS), aggressive fluid management, and the CardioMEMS device (a 3-prong approach) will improve CpcPH (combined pre and post capillary pulmonary hypertension) hemodynamics (Total Pulmonary Resistance \[TPR\] and mPAP). For patients who continue to have an elevate pulmonary vascular resistance (TPR) at Week 16, with ReDS, aggressive fluid management, and the CardioMEMS device should allow successful titration of oral treprostinil by preventing titration related pulmonary edema and by improving hemodynamics, activity monitoring and six minute walk test (6MWT) after 16 weeks of therapy.

Conditions

• Pulmonary Hypertension Due to Left Heart Disease

Interventions

Type	Name	Description
DRUG	Treprostinil Diolamine	Oral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-04-01
• Completion: 2027-04-01
• First posted: 2021-05-12
• Last updated: 2023-06-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study