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

Not Applicable

Recruiting

• Conditions: Pulmonary Arterial Hypertension; Eisenmenger Syndrome
• Interventions: Other: respiratory and exercise therapy

• Registration Number: NCT01397110
• Lead Sponsor: Heidelberg University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Study Start: 2012-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Respiratory and exercise therapy	respiratory and exercise therapy	Randomized, prospective, controlled, blinded study of three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. The control group received conventional rehabilitation without a specific training program. After 15 weeks training is also offered to patients in the control group.

Primary Outcome Measures

Name	Time	Method
Changes in the maximum 6-minute walk distance (6MGT)	up to 15 weeks
Changes in quality of life	up to 15 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in hemodynamics	up to 15 weeks	1. Changes in maximum oxygen uptake; 2. Changes in exercise capacity: 6-minute walk distance, Recumbent Bike (Watts), respiratory economy (EQO2, EQCO2); 3. Improved condition(NYHA class, Borg scale); 4. Changes in Magnetic resonance tomography and echocardiographic parameters of right and left ventricle: size and pump function.; 5. Change of laboratory parameters, which are markers of right heart failure as NTproBNP, interleukins

Trial Locations

Locations (1)

: Center for pulmonary Hypertension, Thoraxclinic Heidelberg; 🇩🇪 Heidelberg, Germany