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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    35
  • sponsor
    Heidelberg University
Updated on 4 October 2022
exercise testing
exercise stress test
assisted ventilation
endarterectomy
cardiopulmonary exercise testing
chronic thromboembolic pulmonary hypertension

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.

Details
Condition Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Treatment exercise and respiratory therapy, sedentary control group
Clinical Study IdentifierNCT00477724
SponsorHeidelberg University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A Screening
Informed consent
Men and women 18 - 75 years
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
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