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 range18 Years – 85 Years

SexALL

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

Timeframe: 16 weeks

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 range18 Years – 85 Years

SexALL

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

Timeframe: 16 weeks