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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00477724
Recruitment Status : Recruiting
First Posted : May 24, 2007
Last Update Posted : December 20, 2019
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Chronic Thromboembolic Pulmonary Hypertension Behavioral: exercise and respiratory therapy Other: sedentary control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2007
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in 6-Minute walking test [ Time Frame: after 3 and 15 weeks compared to baseline ]
  2. Change in quality of life [ Time Frame: baseline and 15 weeks ]

Secondary Outcome Measures :
  1. physical capacity in the ergometer test [ Time Frame: baseline, 3 and 15 weeks ]
  2. change of lung function during 6-minute walking test [ Time Frame: baseline, 3 and 15 weeks ]
  3. noninvasive hemodynamic parameters [ Time Frame: baseline, 3 and 15 weeks ]
  4. change of systolic pulmonary arterial pressure at rest and during exercise [ Time Frame: baseline, 3 and 15 weeks ]
  5. change of WHO functional class [ Time Frame: baseline, 3 and 15 weeks ]
  6. change of perfusion parameters (MRI) [ Time Frame: baseline, 3 and 15 weeks ]
  7. change of respiratory muscle function [ Time Frame: baseline and 15 weeks ]
  8. change of NTproBNP [ Time Frame: baseline, 3 and 15 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A Screening

    1. Informed consent
    2. Men and women 18 - 75 years
    3. 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:

  1. Pregnancy or lactation
  2. Change in medication during the last 2 months
  3. Patients with signs of right heart decompensation
  4. Disease which affects the gait
  5. Unclear diagnosis
  6. Acute illness, infection, fever
  7. Severe lung diseases with FEV1 <50% and TLC< 70% of reference

Information from the National Library of Medicine

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 identifier (NCT number): NCT00477724

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Contact: Ekkehard Gruenig, MD +49 6221 396 80 53

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Thoraxclinic at the University Hospital Heidelberg Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Principal Investigator: Ekkehard Gruenig, MD         
Sponsors and Collaborators
Heidelberg University
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Principal Investigator: Ekkehard Gruenig, MD Thoraxclinic at the University Hospital Heidelberg

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Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, Heidelberg University Identifier: NCT00477724    
Other Study ID Numbers: REHA/CTEPH
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Keywords provided by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University:
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases