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.
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ekkehard Gruenig, MD
- Numéro de téléphone: +49 6221 396 80 53
- E-mail: ekkehard.gruenig@med.uni-heidelberg.de
Lieux d'étude
-
-
Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Allemagne, 69120
- Recrutement
- Thoraxclinic at the University Hospital Heidelberg
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Chercheur principal:
- Ekkehard Gruenig, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: sedentary control group
patients are treated by conventional rehabilitation
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control group with no specific training
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Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change in 6-Minute walking test
Délai: after 3 and 15 weeks compared to baseline
|
after 3 and 15 weeks compared to baseline
|
|
Change in quality of life
Délai: baseline and 15 weeks
|
baseline and 15 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
physical capacity in the ergometer test
Délai: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
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change of lung function during 6-minute walking test
Délai: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
noninvasive hemodynamic parameters
Délai: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
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change of systolic pulmonary arterial pressure at rest and during exercise
Délai: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of WHO functional class
Délai: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of perfusion parameters (MRI)
Délai: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of respiratory muscle function
Délai: baseline and 15 weeks
|
baseline and 15 weeks
|
|
change of NTproBNP
Délai: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REHA/CTEPH
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