- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00477724
Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy
Severe CTEPH leads to an impaired physical capacity and a restricted quality of life and poor prognosis.
Pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located in the central pulmonary vessels and therefore can be operated. By this operation the pulmonary artery pressure can be normalised and the patients' survival improved. Up to now, after successful endarterectomy patients only receive anticoagulation.
Despite operation many patients remain symptomatic and are restricted in their physical capacity. Therefore a hypothesis of this project is that most of the patients, even after successful operation, show peripheral vascular remodelling with a ventilation-perfusion mismatch and elevated pulmonary pressure during exercise.
In this study we aim to analyse how many patients with CTEPH after endarterectomy show elevated pulmonary artery pressures at rest or during exercise and are limited in their physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy.
Another aim is to examine whether exercise and respiratory therapy may improve the patients postoperatively.
Therefore 30 patients with CTEPH > six months after endarterectomy, with ongoing restricted exercise capacity shall be included. After baseline examination in the University hospital Heidelberg the patients receive exercise and respiratory therapy for three weeks. The patients will receive further examinations at the end of rehabilitation after 3 weeks and after 15 weeks. All examinations include medical history, family history, physical examination, ECG and echocardiography at rest and during exercise, cardiopulmonary exercise testing, assessment of the respiratory muscle strength, the SF-36 questionnaire for quality of life, laboratory testing and MRI.
Rehabilitation will be conducted in the clinic for rehabilitation Koenigstuhl, Heidelberg. Participants will be randomised into two groups, a control group receiving a conventional therapy for three weeks, in which physical exertion is to be avoided and a training group with additional exercise and respiratory therapy.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ekkehard Gruenig, MD
- Número de teléfono: +49 6221 396 80 53
- Correo electrónico: ekkehard.gruenig@med.uni-heidelberg.de
Ubicaciones de estudio
-
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Alemania, 69120
- Reclutamiento
- Thoraxclinic at the University Hospital Heidelberg
-
Investigador principal:
- Ekkehard Gruenig, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
A Screening
- Informed consent
- Men and women 18 - 75 years
- Patients ≥ 6 months after endarterectomy because of chronic thromboembolic pulmonary hypertension (CTEPH)
- B Training
See A + all patients who showed a restricted physical capacity in the screening:
- Latent pulmonary hypertension
- Restricted physical capacity
Exclusion Criteria:
- Pregnancy or lactation
- Change in medication during the last 2 months
- Patients with signs of right heart decompensation
- Disease which affects the gait
- Unclear diagnosis
- Acute illness, infection, fever
- Severe lung diseases with FEV1 <50% and TLC< 70% of reference
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: sedentary control group
patients are treated by conventional rehabilitation
|
control group with no specific training
|
|
Comparador activo: exercise and respiratory therapy
rehabilitation with exercise and respiratory therapy
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exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in 6-Minute walking test
Periodo de tiempo: after 3 and 15 weeks compared to baseline
|
after 3 and 15 weeks compared to baseline
|
|
Change in quality of life
Periodo de tiempo: baseline and 15 weeks
|
baseline and 15 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
physical capacity in the ergometer test
Periodo de tiempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of lung function during 6-minute walking test
Periodo de tiempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
noninvasive hemodynamic parameters
Periodo de tiempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of systolic pulmonary arterial pressure at rest and during exercise
Periodo de tiempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of WHO functional class
Periodo de tiempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of perfusion parameters (MRI)
Periodo de tiempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of respiratory muscle function
Periodo de tiempo: baseline and 15 weeks
|
baseline and 15 weeks
|
|
change of NTproBNP
Periodo de tiempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REHA/CTEPH
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