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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397110
First Posted: July 19, 2011
Last Update Posted: June 22, 2015
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.
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
  Purpose
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

Condition Intervention Phase
Pulmonary Arterial Hypertension Eisenmenger Syndrome Other: respiratory and exercise therapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Prof. Dr. med. Ekkehard Gruenig, Heidelberg University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: respiratory and exercise therapy
Conventional therapy with specific respiratory and physical therapy plus mental walking training
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397110


Contacts
Contact: Ekkehard Gruenig, MD +49 6221 396 8053 ekkehard.gruenig@med.uni-heidelberg.de

Locations
Germany
: Center for pulmonary Hypertension, Thoraxclinic Heidelberg Recruiting
Heidelberg, Germany, 69126
Principal Investigator: Ekkehard Gruenig, MD         
Sponsors and Collaborators
Heidelberg University
Investigators
Study Chair: Ekkehard Gruenig, MD Center for pulmonary hypertension, Thoraxclinic Heidelberg
  More Information

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, Heidelberg University
ClinicalTrials.gov Identifier: NCT01397110     History of Changes
Other Study ID Numbers: 2011-07-12
First Submitted: July 13, 2011
First Posted: July 19, 2011
Last Update Posted: June 22, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Syndrome
Hypertension
Familial Primary Pulmonary Hypertension
Heart Defects, Congenital
Eisenmenger Complex
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities