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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397110
Recruitment Status : Unknown
Verified June 2015 by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University.
Recruitment status was:  Recruiting
First Posted : July 19, 2011
Last Update Posted : June 22, 2015
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University

July 13, 2011
July 19, 2011
June 22, 2015
January 2012
December 2016   (Final data collection date for primary outcome measure)
  • Changes in the maximum 6-minute walk distance (6MGT) [ Time Frame: up to 15 weeks ]
  • Changes in quality of life [ Time Frame: up to 15 weeks ]
Same as current
Complete list of historical versions of study NCT01397110 on Archive Site
Changes in hemodynamics [ Time Frame: 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
Same as current
Not Provided
Not Provided
Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
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
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
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Pulmonary Arterial Hypertension
  • Eisenmenger Syndrome
Other: respiratory and exercise therapy
Conventional therapy with specific respiratory and physical therapy plus mental walking training
  • Active Comparator: 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.
    Intervention: Other: respiratory and exercise therapy
  • No Intervention: Control group without exercise training

    patients of the control group continue their sedentary lifestyle without given advice for exercise training.

    The time before start of rehabilitation (three months) serves as control group. Afterwards patients take part in the training program as well.

Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
Heidelberg University
Not Provided
Study Chair: Ekkehard Gruenig, MD Center for pulmonary hypertension, Thoraxclinic Heidelberg
Heidelberg University
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP