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O estudo clínico NCT06941441 para Hipertensão arterial pulmonar (HAP), Terapia de exercício está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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PAH Exercise Study

Recrutando
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT06941441 procura avaliar o tratamento para Hipertensão arterial pulmonar (HAP), Terapia de exercício. Este é um ensaio intervencionista de Fase III. Seu status atual é: recrutando. O estudo começou em 15 de abril de 2025 e pretende incluir 10 participantes. Coordenado por a Universidade de Washington e deve ser concluído em 30 de setembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 23 de abril de 2025.
Resumo
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.
Título oficial

Remotely-Monitored Exercise to Enhance Functional Outcomes in Patients With Pulmonary Arterial Hypertension (PAH) Initiating Sotatercept Therapy: A Single-site Feasibility Study

Condições
Hipertensão arterial pulmonar (HAP)Terapia de exercício
Outros IDs do estudo
  • STUDY00021808
Número NCT
NCT06941441
Data de início (real)
2025-04-15
Última atualização postada
2025-04-23
Data de conclusão (estimada)
2026-09-30
Inscrição (estimada)
10
Tipo de estudo
Intervencionista
FASE
Fase III
Status
Recrutando
Palavras-chave
PAH
pulmonary arterial hypertension
sotatercept
exercise
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalExercise Arm
Patients with PAH on sotatercept plus a tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring
Programa de exercícios em casa
A tailored, progressive home exercise program with wrist-worn fitness tracker and oxygen saturation monitoring
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
Recruitment rate
18 months
Adherence and Completion Rate
18 months
Study-related adverse events (SAE) rate
18 months
Measurement fidelity for the innovative 'remote Six Minute Walk Test (6MWT)'
Patient self-administered via the digital fitness platform with remote monitoring at two interim assessment timepoints
18 months
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
Change from baseline in Six Minute Walk Test (6MWT) distance
Via Six Minute Walk Test administered during baseline and final in-person study visits
24 weeks
Change from baseline in Calculated Cardiac Effort (CEC) during 6MWT
Cardiac Effort to be calculated from Six Minute Walk Test administered during baseline and final in-person study visits
24 weeks
Change from baseline in nT-proBNP
Via bloodwork during baseline and final in-person study visits
24 weeks
Average weekly accelerometry minutes of moderate-to-vigorous physical activity (MVPA)
24 weeks
Health-related quality of life (QoL)
As measured by the PAH-specific survey PAH-SYMPACT®
24 weeks
Critérios de elegibilidade

Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
  • 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

  • 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
University of Washington logoUniversidade de Washington398 estudos clínicos ativos para explorar
Responsável pelo estudo
Mary Beth Brown, Investigador principal, Associate Professor, Department of Rehabilitation Medicine, University of Washington
Contato central do estudo
Contato: Claire E Child, DPT, MPH, 206-616-8601, [email protected]
1 Locais do estudo em 1 países

Washington

University of Washington, Seattle, Washington, 98195, United States
Claire E Child, DPT, MPH, Contato, 206-616-8601, [email protected]
Recrutando