WithdrawnPhase 2

Telemonitoring to Treat Group 2 Pulmonary Hypertension

Stopped: never opened to enrollment because it was never funded

United States0Started 2023-04

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Total lung capacity is ≥ 60% of the predicted value.
. Forced expiratory volume at 1 second (FEV1) is ≥50% of the predicted value.
. Diffusing capacity of the lungs for carbon monoxide (DLCO) is ≥ 32% of the predicted value (unadjusted or adjusted for alveolar volume).

Exclusion criteria

. Greater than mild aortic and/or mitral stenosis
. Severe mitral and/or aortic regurgitation (\>Grade 3)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with normal lung impedance as measured by the ReDS vest in Ohms at Week 16

Timeframe: 16 weeks

Number of participants with normal total pulmonary resistance as measured by CardioMEMS in Woods Units at Week 16

Timeframe: 16 weeks

Number of participants reaching normal lung impedance with oral treprostinil at Week 32

Timeframe: 16 weeks

Number of participants reaching normal total pulmonary resistance with oral treprostinil at Week 32

Timeframe: 16 weeks

Number of participants decreasing six-minute walk distance with oral treprostinil at Week 32

Timeframe: 16 weeks

Number of participants maintaining normal lung impedance as measured by the ReDS vest at Week 32

Timeframe: 16 weeks

Number of participants maintaining total pulmonary resistance as measured by CardioMEMS at Week 32

Trial details

NCT IDNCT04882774

SponsorMardi Gomberg -Maitland MD, MSc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04

View on ClinicalTrials.gov More Pulmonary Hypertension Due to Left Heart Disease trials

Plain-language summary

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Total lung capacity is ≥ 60% of the predicted value.
. Forced expiratory volume at 1 second (FEV1) is ≥50% of the predicted value.
. Diffusing capacity of the lungs for carbon monoxide (DLCO) is ≥ 32% of the predicted value (unadjusted or adjusted for alveolar volume).

Exclusion criteria

. Greater than mild aortic and/or mitral stenosis
. Severe mitral and/or aortic regurgitation (\>Grade 3)

What they're measuring

Number of participants with normal lung impedance as measured by the ReDS vest in Ohms at Week 16

Timeframe: 16 weeks

Number of participants with normal total pulmonary resistance as measured by CardioMEMS in Woods Units at Week 16

Timeframe: 16 weeks

Number of participants reaching normal lung impedance with oral treprostinil at Week 32

Timeframe: 16 weeks

Number of participants reaching normal total pulmonary resistance with oral treprostinil at Week 32

Timeframe: 16 weeks

Number of participants decreasing six-minute walk distance with oral treprostinil at Week 32

Timeframe: 16 weeks

Number of participants maintaining normal lung impedance as measured by the ReDS vest at Week 32

Timeframe: 16 weeks

Number of participants maintaining total pulmonary resistance as measured by CardioMEMS at Week 32