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

This study is currently recruiting participants.
Verified March 2012 by University of Heidelberg
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01397110
First received: July 13, 2011
Last updated: March 9, 2012
Last verified: March 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Changes in the maximum 6-minute walk distance (6MGT) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
  • Changes in quality of life [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in hemodynamics [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
    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: June 2014
Estimated Primary Completion Date: December 2013 (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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397110

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

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

No publications provided

Responsible Party: Prof. Dr. med. Ekkehard Gruenig, Prof. Dr. med. Ekkehard Grünig, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01397110     History of Changes
Other Study ID Numbers: 2011-07-12
Study First Received: July 13, 2011
Last Updated: March 9, 2012
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hypertension, Pulmonary
Eisenmenger Complex
Heart Defects, Congenital
Hypertension
Lung Diseases
Respiratory Tract Diseases
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013