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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Oral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID
George Washington University
Washington D.C., District of Columbia, United States
Ohio State University
Columbus, Ohio, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States
Number of participants with normal lung impedance as measured by the ReDS vest in Ohms at Week 16
Number of participants reaching normal lung impedance (\< 34 Ω) based on ReDS vest management.
Time frame: 16 weeks
Number of participants with normal total pulmonary resistance as measured by CardioMEMS in Woods Units at Week 16
Number of participants reaching normal total pulmonary resistance (\< 5 Woods Units) as measured by CardioMEMS.
Time frame: 16 weeks
Number of participants reaching normal lung impedance with oral treprostinil at Week 32
Number of participants reaching normal lung impedance (\<34 Ω) from Week 16 to Week 32 with oral treprostinil administration.
Time frame: 16 weeks
Number of participants reaching normal total pulmonary resistance with oral treprostinil at Week 32
Number of participants reaching normal total pulmonary resistance (goal \< 5 U) from Week 16 to Week 32 with oral treprostinil administration.
Time frame: 16 weeks
Number of participants decreasing six-minute walk distance with oral treprostinil at Week 32
Number of participants with a six-minute walk distance decrease of \>15% from Week 16 to Week 32 with oral treprostinil administration.
Time frame: 16 weeks
Number of participants maintaining normal lung impedance as measured by the ReDS vest at Week 32
Number of participants maintaining normal lung impedance (\< 34 Ω) from Week 16 to Week 32 as measured by ReDS vest.
Time frame: 16 weeks
Number of participants maintaining total pulmonary resistance as measured by CardioMEMS at Week 32
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Number of participants maintaining normal TPR (\< 5 U) from Week 16 to Week 32 as measured by CardioMEMS.
Time frame: 16 weeks
WHO Functional Class
Change in Functional Class (FC) Week 16, 32.
Time frame: 32 weeks
Change in cardiac output
Change in cardiac output (L/min) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in cardiac index
Change in cardiac index (L/min/m2) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in right ventricular stroke volume
Change in right ventricular stroke volume (mL) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in stroke volume index
Change in stroke volume index (mL/m2) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in elastance
Change in elastance (mmHg/mL) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in compliance
Change in compliance (mL/mmHg) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in right ventricular power
Change in right ventricular power (W) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in cardiac efficiency
Change in cardiac efficiency (mL/mmHg) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in right ventricular stroke work
Change in right ventricular stroke work (mmHg/mL) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in stroke work index
Change in stroke work index (g x m/m2) as measured by CardioMEMS from Baseline to Week 16, 32.
Time frame: 32 weeks
Change in NT-proBNP
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from Baseline to Week 16, 32.
Time frame: 32 weeks
Kansas City Cardiomyopathy Questionnaire
Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) at Baseline to Week 16 and baseline to Week 32. Scores are scaled from 0 to 100 and summarized in quartiles representing health status with higher scores indicating better status: 0 to 24=very poor to poor; 25 to 49=poor to fair; 50 to 74=fair to good; and 75 to 100= good to excellent.
Time frame: 32 weeks
Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire
Improvement in PAH-SYMPACT at Baseline to Week 16, Baseline to Week 32. Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire with higher scores indicating greater symptom severity or worse impact: scale of 0=no, 1=mild, 2=moderate, 3=severe, and 4=very severe.
Time frame: 32 weeks
Number of participants with heart failure exacerbation
Adjudicated hospitalization or emergency department visits due to a heart failure decompensation.
Time frame: 32 weeks
Six-minute walk test
Decrease in 6MWT \>15% from Baseline (or too ill to walk) directly related to disease under study at 2 consecutive visits on different days.
Time frame: 32 weeks
Number of participants who experienced mortality
Heart failure related deaths and all-cause mortality.
Time frame: 32 weeks