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

This study is currently recruiting participants.
Verified March 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00477724
First received: May 22, 2007
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention
Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
 Behavioral: exercise and respiratory therapy
Other: sedentary control group

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Change in 6-Minute walking test [ Time Frame: after 3 and 15 weeks compared to baseline ] [ Designated as safety issue: No ]
  • Change in quality of life [ Time Frame: baseline and 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physical capacity in the ergometer test [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of lung function during 6-minute walking test [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • noninvasive hemodynamic parameters [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of systolic pulmonary arterial pressure at rest and during exercise [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of WHO functional class [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of perfusion parameters (MRI) [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of respiratory muscle function [ Time Frame: baseline and 15 weeks ] [ Designated as safety issue: No ]
  • change of NTproBNP [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: June 2007
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00477724

Contacts
Contact: Ekkehard Gruenig, MD +49 6221 396 80 53 ekkehard.gruenig@thoraxklinik-heidelberg.de

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

Publications:

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00477724     History of Changes
Other Study ID Numbers: REHA/CTEPH
Study First Received: May 22, 2007
Last Updated: March 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
latent

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013