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โ† Trials
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PAH Exercise Study

RecruitingPhase 3Ages 18 Years - anyAllUniversity of Washington
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In plain words

What the trial is, and whether it could suit you

Ten patients with PAH who are stable and eligible to initiate sotatercept therapy will participate in a 26 week study that consists of a 24-week intervention period where patients will receive complimentary sotatercept as prescribed, plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years * Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of WHO PAH Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with CTD, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair * Symptomatic PH classified as WHO FC II or III * Baseline RHC performed during the Screening Period documenting a minimum PVR of โ‰ฅ 5 WU and a pulmonary capillary wedge (PCWP) or left ventricular end-diastolic pressure of โ‰ค 15 mmHg * Receiving stable background therapy for PAH for \>90 days and will continue receiving throughout trial. Background treatments may consist of monotherapy, double therapy, or triple therapy with currently available medications for PAH. * Initiation of Sotatercept is clinically indicated * Willing and able to participate in a remotely-monitored home exercise program for 24 weeks * Ability to adhere to study visit schedule and understand and comply with all protocol requirements * Ability to understand and provide written informed consent Exclusion Criteria: * Diagnosis of PH WHO Groups 2, 3, 4, or 5 * Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease * Hemoglobin at screening above gender-specific ULN * Baseline platelet count \< 50,000/mm3 (\< 50.0 ร— 109/L) at screening * Uncontrolled systemic hypertension as evidenced by sitting systolic BP \> 160 mmHg or sitting diastolic BP \> 100 mmHg during screening visit after a period of rest; Baseline systolic BP \< 90 mmHg at screening * Pregnant or breastfeeding females * Clinical laboratory liver and kidney function tests outside of normal range * Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent * Prior exposure to sotatercept (ACE-011) or luspatercept (ACE-536) or known allergic reaction to either one * History of full pneumonectomy * Initiation of a structured exercise program within 90 days prior or planned initiation during the study * Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C). * Cardiac related history: History of restrictive, constrictive, or congestive cardiomyopathy; History of atrial septostomy within 180 days prior to the screening visit; ECG with Fridericia's corrected QT interval (QTcF) \> 500 ms during the Screening Period; Personal or family history of long QT syndrome (LQTS) or sudden cardiac death; Left ventricular ejection fraction (LVEF) \< 45% on historical ECHO within 12 months prior to the screening visit; Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions * Cerebrovascular accident within 3 months prior to the screening visit * Acutely decompensated heart failure within 14 days prior to the screening visit, as per investigator assessment * Significant (โ‰ฅ 2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease * Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit
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What it tests

  • Home exercise program
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Where

1 site
University of Washington
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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