Back to resultsRespiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
Primary Purpose
Pulmonary Arterial Hypertension, Eisenmenger Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
respiratory and exercise therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Pulmonary Arterial Hypertension
Eligibility 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
Sites / Locations
- : Center for pulmonary Hypertension, Thoraxclinic HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Respiratory and exercise therapy
Control group without exercise training
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Changes in the maximum 6-minute walk distance (6MGT)
Changes in quality of life
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01397110
Brief Title
Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension, Eisenmenger Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Respiratory and exercise therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group without exercise training
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
respiratory and exercise therapy
Intervention Description
Conventional therapy with specific respiratory and physical therapy plus mental walking training
Primary Outcome Measure Information:
Title
Changes in the maximum 6-minute walk distance (6MGT)
Time Frame
up to 15 weeks
Title
Changes in quality of life
Time Frame
up to 15 weeks
Secondary Outcome Measure Information:
Title
Changes in hemodynamics
Description
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
Time Frame
up to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekkehard Gruenig, MD
Phone
+49 6221 396 8053
Email
ekkehard.gruenig@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekkehard Gruenig, MD
Organizational Affiliation
Center for pulmonary hypertension, Thoraxclinic Heidelberg
Official's Role
Study Chair
Facility Information:
Facility Name
: Center for pulmonary Hypertension, Thoraxclinic Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekkehard Gruenig, MD
12. IPD Sharing Statement
Learn more about this trial
Respiratory and Physical Therapy in Patients With Associated Pulmonary Arterial Hypertension (APAH) With Congenital Heart Defects
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