Telemonitoring to Treat Group 2 Pulmonary Hypertension

Exclusion Criteria

• •The subject is pregnant or lactating.
• •In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH.
• •The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation of therapy or inability to effectively titrate that therapy.
• •The subject has received PAH therapies, including prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), nonprostanoid IP receptor agonist (selexipag), ERA, or soluble guanylate cyclase stimulator, within 30 days of enrollment. If the Investigator does not intend to keep a subject on their PDE5-I therapy, it must be stopped at least 30 days prior to enrollment. Intermittent use of a PDE5-I (≤3 times per week) to treat erectile dysfunction is permitted.
• •The subject has been hospitalized for a cardiopulmonary indication within 30 days of randomization.
• •The subject had a myocardial infarction within 90 days of enrollment.
• •The subject had cardiac resynchronization therapy within 90 days of enrollment or anticipated resynchronization therapy during the study treatment period.
• •The subject has liver function tests (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]) greater than 3 times the upper limit of normal at Screening, clinically significant liver disease/dysfunction per Investigator's clinical judgement, known Child-Pugh Class C hepatic disease or noncirrhotic portal hypertension.
• •The subject has uncontrolled systemic hypertension, defined as a systolic blood pressure \>160 mmHg or a diastolic blood pressure \>110 mmHg at Baseline on more than one occasion during screening.
• •The subject has a systolic blood pressure \<100 mmHg at Baseline.
• •The subject has a resting heart rate \>110 beats per minute at Baseline.
• •The subject has sarcoidosis or cardiac amyloidosis.
• •The subject has a known history of any LVEF less than 40% by ECHO within 3 years of enrollment. Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition (e.g., atrial fibrillation) is allowed.
• •The subject has hemodynamically significant valvular heart disease as determined by the Investigator, including:
• •1. Greater than mild aortic and/or mitral stenosis
• •2. Severe mitral and/or aortic regurgitation (\>Grade 3)
• •The subject has a body mass index \>45 kg/m2.
• •The subject has any musculoskeletal disorder (e.g., arthritis affecting the lower limbs, recent hip or knee joint replacement, artificial leg), or has any other condition that would likely be the primary limit to ambulation as opposed to the disease under study.
• •The subject has end-stage renal disease requiring/receiving dialysis.
• •The subject has used any investigational drug/device, or participated in any investigational study, within 30 days prior to the Baseline visit.