Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects

  • STATUS
    Recruiting
  • End date
    Dec 21, 2025
  • participants needed
    50
  • sponsor
    Heidelberg University
Updated on 4 October 2022
hypertension
congenital heart defects
apah

Summary

The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome

Details
Condition Pulmonary Arterial Hypertension, Eisenmenger Syndrome
Treatment respiratory and exercise therapy
Clinical Study IdentifierNCT01397110
SponsorHeidelberg University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

signed consent form
men and women> 18 years <80 years
APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)

Exclusion Criteria

Pregnancy or lactation
Change in medication during the last 2 months
severe walking disturbance
uncertain diagnoses
No previous invasively confirmation of PH
acute diseases, infections, fever
Serious lung disease with FEV1 <50% or TLC <70% of target
Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, recurrent syncope within 4 weeks before study entry
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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