Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
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|ClinicalTrials.gov Identifier: NCT00477724|
Recruitment Status : Recruiting
First Posted : May 24, 2007
Last Update Posted : December 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Chronic Thromboembolic Pulmonary Hypertension||Behavioral: exercise and respiratory therapy Other: sedentary control group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy|
|Study Start Date :||June 2007|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Placebo Comparator: sedentary control group
patients are treated by conventional rehabilitation
Other: sedentary control group
control group with no specific training
Active Comparator: exercise and respiratory therapy
rehabilitation with exercise and respiratory therapy
Behavioral: exercise and respiratory therapy
exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
- Change in 6-Minute walking test [ Time Frame: after 3 and 15 weeks compared to baseline ]
- Change in quality of life [ Time Frame: baseline and 15 weeks ]
- physical capacity in the ergometer test [ Time Frame: baseline, 3 and 15 weeks ]
- change of lung function during 6-minute walking test [ Time Frame: baseline, 3 and 15 weeks ]
- noninvasive hemodynamic parameters [ Time Frame: baseline, 3 and 15 weeks ]
- change of systolic pulmonary arterial pressure at rest and during exercise [ Time Frame: baseline, 3 and 15 weeks ]
- change of WHO functional class [ Time Frame: baseline, 3 and 15 weeks ]
- change of perfusion parameters (MRI) [ Time Frame: baseline, 3 and 15 weeks ]
- change of respiratory muscle function [ Time Frame: baseline and 15 weeks ]
- change of NTproBNP [ Time Frame: baseline, 3 and 15 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477724
|Contact: Ekkehard Gruenig, MD||+49 6221 396 80 firstname.lastname@example.org|
|Thoraxclinic at the University Hospital Heidelberg||Recruiting|
|Heidelberg, Baden-Wuerttemberg, Germany, 69120|
|Principal Investigator: Ekkehard Gruenig, MD|
|Principal Investigator:||Ekkehard Gruenig, MD||Thoraxclinic at the University Hospital Heidelberg|