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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ekkehard Gruenig, MD
- Telefoonnummer: +49 6221 396 80 53
- E-mail: ekkehard.gruenig@med.uni-heidelberg.de
Studie Locaties
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Duitsland, 69120
- Werving
- Thoraxclinic at the University Hospital Heidelberg
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Hoofdonderzoeker:
- Ekkehard Gruenig, MD
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Placebo-vergelijker: sedentary control group
patients are treated by conventional rehabilitation
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control group with no specific training
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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change in 6-Minute walking test
Tijdsspanne: 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
Tijdsspanne: baseline and 15 weeks
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baseline and 15 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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physical capacity in the ergometer test
Tijdsspanne: 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
Tijdsspanne: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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noninvasive hemodynamic parameters
Tijdsspanne: 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
Tijdsspanne: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of WHO functional class
Tijdsspanne: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of perfusion parameters (MRI)
Tijdsspanne: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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change of respiratory muscle function
Tijdsspanne: baseline and 15 weeks
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baseline and 15 weeks
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change of NTproBNP
Tijdsspanne: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REHA/CTEPH
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