Clinical Trial: Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Th

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

Detailed Summary:
Sponsor: Heidelberg University

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • Change in 6-Minute walking test [ Time Frame: after 3 and 15 weeks compared to baseline ]
  • Change in quality of life


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • physical capacity in the ergometer test
  • change of lung function during 6-minute walking test
  • noninvasive hemodynamic parameters
  • change of systolic pulmonary arterial pressure at rest and during exercise
  • change of WHO functional class
  • change of perfusion parameters (MRI)
  • change of respiratory muscle function
  • change of NTproBNP


Information By: Heidelberg University

Dates:
Date Received: May 22, 2007
Date Started: June 2007
Date Completion:
Last Updated: July 1, 2014
Last Verified: July 2014