Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
Recruitment status was: Recruiting
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 Hypertension Chronic Thromboembolic Pulmonary Hypertension||Behavioral: exercise and respiratory therapy Other: sedentary control group|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy|
- 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 ]
|Study Start Date:||June 2007|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477724
|Contact: Ekkehard Gruenig, MD||+49 6221 396 80 email@example.com|
|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|