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

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00477724

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

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: Exercise and Physical Fitness High Blood Pressure Pulmonary Hypertension Rehabilitation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, 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

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 ]
Change in quality of life

Secondary Outcome Measures:

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

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:

Pregnancy or lactation
Change in medication during the last 2 months
Patients with signs of right heart decompensation
Disease which affects the gait
Unclear diagnosis
Acute illness, infection, fever
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, Baden-Wuerttemberg
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:

Mereles D, Ewert R, Lodziewski S, Borst MM, Benz A, Olschewski H, Grunig E. Effect of Inhaled Iloprost during Off-Medication Time in Patients with Pulmonary Arterial Hypertension. Respiration. 2007 Apr 20; [Epub ahead of print]

Study ID Numbers:	REHA/CTEPH
Study First Received:	May 22, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00477724
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

latent

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009