Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477724
Status:
UNKNOWN
Last Update Posted:
2022-07-14
First Post:
2007-05-22
Brief Title:
Latent Pulmonary Hypertension PH in Chronic Thromboembolic Pulmonary Hypertension CTEPH After Endarterectomy and Influence of Exercise and Respiratory Therapy
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None