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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life in Patients With Severe Associated Pulmonary Arterial Hypertension (APAH) as Part of a Congenital Heart Defect With / Without Eisenmenger's Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01397110
• Other study ID #: 2011-07-12
• Status: Recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 2025

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: Ekkehard Gruenig, MD
• Phone: +49 6221 396 8053
• Email: ekkehard.gruenig[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eisenmenger Complex
• Eisenmenger Syndrome
• Familial Primary Pulmonary Hypertension
• Heart Defects, Congenital
• Hypertension
• Pulmonary Arterial Hypertension
• Syndrome

Intervention

Other:
• respiratory and exercise therapy
Conventional therapy with specific respiratory and physical therapy plus mental walking training

Locations

Country	Name	City	State
Germany	: Center for pulmonary Hypertension, Thoraxclinic Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the maximum 6-minute walk distance (6MGT)		up to 15 weeks
Primary	Changes in quality of life		up to 15 weeks
Secondary	Changes in hemodynamics	Changes in maximum oxygen uptake; Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2); Improved condition(NYHA class, Borg scale); Changes in Magnetic resonance tomography and echocardiographic parameters of right and left ventricle: size and pump function.; Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins	up to 15 weeks