- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Ekkehard Gruenig, MD
- Numero di telefono: +49 6221 396 80 53
- Email: ekkehard.gruenig@med.uni-heidelberg.de
Luoghi di studio
-
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Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, Germania, 69120
- Reclutamento
- Thoraxclinic at the University Hospital Heidelberg
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Investigatore principale:
- Ekkehard Gruenig, MD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore placebo: sedentary control group
patients are treated by conventional rehabilitation
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control group with no specific training
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|
Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in 6-Minute walking test
Lasso di tempo: 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
Lasso di tempo: baseline and 15 weeks
|
baseline and 15 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
physical capacity in the ergometer test
Lasso di tempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of lung function during 6-minute walking test
Lasso di tempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
noninvasive hemodynamic parameters
Lasso di tempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of systolic pulmonary arterial pressure at rest and during exercise
Lasso di tempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of WHO functional class
Lasso di tempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of perfusion parameters (MRI)
Lasso di tempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of respiratory muscle function
Lasso di tempo: baseline and 15 weeks
|
baseline and 15 weeks
|
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change of NTproBNP
Lasso di tempo: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- REHA/CTEPH
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .