NCT06941441招募中3 期
Remotely-Monitored Exercise to Enhance Functional Outcomes in Patients With Pulmonary Arterial Hypertension (PAH) Initiating Sotatercept Therapy: A Single-site Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 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 ≥ 5 WU and a pulmonary capillary wedge (PCWP) or left ventricular end-diastolic pressure of ≤ 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
排除标准
- •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 × 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 (≥ 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
研究组 & 干预措施
Exercise Arm
Experimental
Patients with PAH on sotatercept plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring
干预措施: Home exercise program (Other)
结局指标
主要结局
Recruitment rate
时间窗: 18 months
Adherence and Completion Rate
时间窗: 18 months
Study-related adverse events (SAE) rate
时间窗: 18 months
Measurement fidelity for the innovative 'remote Six Minute Walk Test (6MWT)'
时间窗: 18 months
Patient self-administered via the digital fitness platform with remote monitoring at two interim assessment timepoints
次要结局
- Change from baseline in Six Minute Walk Test (6MWT) distance(24 weeks)
- Change from baseline in Calculated Cardiac Effort (CEC) during 6MWT(24 weeks)
- Change from baseline in nT-proBNP(24 weeks)
- Average weekly accelerometry minutes of moderate-to-vigorous physical activity (MVPA)(24 weeks)
- Health-related quality of life (QoL)(24 weeks)
研究者
Mary Beth Brown
Associate Professor, Department of Rehabilitation Medicine
University of Washington
研究点 (1)
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