- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ekkehard Gruenig, MD
- Telefonnummer: +49 6221 396 80 53
- E-mail: ekkehard.gruenig@med.uni-heidelberg.de
Studiesteder
-
-
Baden-Wuerttemberg
-
Heidelberg, Baden-Wuerttemberg, Tyskland, 69120
- Rekruttering
- Thoraxclinic at the University Hospital Heidelberg
-
Ledende efterforsker:
- Ekkehard Gruenig, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: sedentary control group
patients are treated by conventional rehabilitation
|
control group with no specific training
|
|
Aktiv komparator: exercise and respiratory therapy
rehabilitation with exercise and respiratory therapy
|
exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in 6-Minute walking test
Tidsramme: after 3 and 15 weeks compared to baseline
|
after 3 and 15 weeks compared to baseline
|
|
Change in quality of life
Tidsramme: baseline and 15 weeks
|
baseline and 15 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
physical capacity in the ergometer test
Tidsramme: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of lung function during 6-minute walking test
Tidsramme: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
noninvasive hemodynamic parameters
Tidsramme: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of systolic pulmonary arterial pressure at rest and during exercise
Tidsramme: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of WHO functional class
Tidsramme: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of perfusion parameters (MRI)
Tidsramme: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of respiratory muscle function
Tidsramme: baseline and 15 weeks
|
baseline and 15 weeks
|
|
change of NTproBNP
Tidsramme: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REHA/CTEPH
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