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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ekkehard Gruenig, MD
- Número de telefone: +49 6221 396 80 53
- E-mail: ekkehard.gruenig@med.uni-heidelberg.de
Locais de estudo
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Alemanha, 69120
- Recrutamento
- Thoraxclinic at the University Hospital Heidelberg
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Investigador principal:
- Ekkehard Gruenig, MD
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: sedentary control group
patients are treated by conventional rehabilitation
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control group with no specific training
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Comparador Ativo: 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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Change in 6-Minute walking test
Prazo: after 3 and 15 weeks compared to baseline
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after 3 and 15 weeks compared to baseline
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Change in quality of life
Prazo: baseline and 15 weeks
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baseline and 15 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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physical capacity in the ergometer test
Prazo: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of lung function during 6-minute walking test
Prazo: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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noninvasive hemodynamic parameters
Prazo: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of systolic pulmonary arterial pressure at rest and during exercise
Prazo: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of WHO functional class
Prazo: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of perfusion parameters (MRI)
Prazo: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of respiratory muscle function
Prazo: baseline and 15 weeks
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baseline and 15 weeks
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change of NTproBNP
Prazo: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REHA/CTEPH
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