Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
Primary Purpose
Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
exercise and respiratory therapy
sedentary control group
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring latent
Eligibility Criteria
Inclusion Criteria:
A Screening
- Informed consent
- Men and women 18 - 75 years
- Patients ≥ 6 months after endarterectomy because of chronic thromboembolic pulmonary hypertension (CTEPH)
- B Training
See A + all patients who showed a restricted physical capacity in the screening:
- Latent pulmonary hypertension
- Restricted physical capacity
Exclusion Criteria:
- Pregnancy or lactation
- Change in medication during the last 2 months
- Patients with signs of right heart decompensation
- Disease which affects the gait
- Unclear diagnosis
- Acute illness, infection, fever
- Severe lung diseases with FEV1 <50% and TLC< 70% of reference
Sites / Locations
- Thoraxclinic at the University Hospital HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
sedentary control group
exercise and respiratory therapy
Arm Description
patients are treated by conventional rehabilitation
rehabilitation with exercise and respiratory therapy
Outcomes
Primary Outcome Measures
Change in 6-Minute walking test
Change in quality of life
Secondary Outcome Measures
physical capacity in the ergometer test
change of lung function during 6-minute walking test
noninvasive hemodynamic parameters
change of systolic pulmonary arterial pressure at rest and during exercise
change of WHO functional class
change of perfusion parameters (MRI)
change of respiratory muscle function
change of NTproBNP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00477724
Brief Title
Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
Official Title
Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
5. Study Description
Brief Summary
Severe CTEPH leads to an impaired physical capacity and a restricted quality of life and poor prognosis.
Pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located in the central pulmonary vessels and therefore can be operated. By this operation the pulmonary artery pressure can be normalised and the patients' survival improved. Up to now, after successful endarterectomy patients only receive anticoagulation.
Despite operation many patients remain symptomatic and are restricted in their physical capacity. Therefore a hypothesis of this project is that most of the patients, even after successful operation, show peripheral vascular remodelling with a ventilation-perfusion mismatch and elevated pulmonary pressure during exercise.
In this study we aim to analyse how many patients with CTEPH after endarterectomy show elevated pulmonary artery pressures at rest or during exercise and are limited in their physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy.
Another aim is to examine whether exercise and respiratory therapy may improve the patients postoperatively.
Therefore 30 patients with CTEPH > six months after endarterectomy, with ongoing restricted exercise capacity shall be included. After baseline examination in the University hospital Heidelberg the patients receive exercise and respiratory therapy for three weeks. The patients will receive further examinations at the end of rehabilitation after 3 weeks and after 15 weeks. All examinations include medical history, family history, physical examination, ECG and echocardiography at rest and during exercise, cardiopulmonary exercise testing, assessment of the respiratory muscle strength, the SF-36 questionnaire for quality of life, laboratory testing and MRI.
Rehabilitation will be conducted in the clinic for rehabilitation Koenigstuhl, Heidelberg. Participants will be randomised into two groups, a control group receiving a conventional therapy for three weeks, in which physical exertion is to be avoided and a training group with additional exercise and respiratory therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension
Keywords
latent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sedentary control group
Arm Type
Placebo Comparator
Arm Description
patients are treated by conventional rehabilitation
Arm Title
exercise and respiratory therapy
Arm Type
Active Comparator
Arm Description
rehabilitation with exercise and respiratory therapy
Intervention Type
Behavioral
Intervention Name(s)
exercise and respiratory therapy
Intervention Description
exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
Intervention Type
Other
Intervention Name(s)
sedentary control group
Intervention Description
control group with no specific training
Primary Outcome Measure Information:
Title
Change in 6-Minute walking test
Time Frame
after 3 and 15 weeks compared to baseline
Title
Change in quality of life
Time Frame
baseline and 15 weeks
Secondary Outcome Measure Information:
Title
physical capacity in the ergometer test
Time Frame
baseline, 3 and 15 weeks
Title
change of lung function during 6-minute walking test
Time Frame
baseline, 3 and 15 weeks
Title
noninvasive hemodynamic parameters
Time Frame
baseline, 3 and 15 weeks
Title
change of systolic pulmonary arterial pressure at rest and during exercise
Time Frame
baseline, 3 and 15 weeks
Title
change of WHO functional class
Time Frame
baseline, 3 and 15 weeks
Title
change of perfusion parameters (MRI)
Time Frame
baseline, 3 and 15 weeks
Title
change of respiratory muscle function
Time Frame
baseline and 15 weeks
Title
change of NTproBNP
Time Frame
baseline, 3 and 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A Screening
Informed consent
Men and women 18 - 75 years
Patients ≥ 6 months after endarterectomy because of chronic thromboembolic pulmonary hypertension (CTEPH)
B Training
See A + all patients who showed a restricted physical capacity in the screening:
Latent pulmonary hypertension
Restricted physical capacity
Exclusion Criteria:
Pregnancy or lactation
Change in medication during the last 2 months
Patients with signs of right heart decompensation
Disease which affects the gait
Unclear diagnosis
Acute illness, infection, fever
Severe lung diseases with FEV1 <50% and TLC< 70% of reference
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekkehard Gruenig, MD
Phone
+49 6221 396 80 53
Email
ekkehard.gruenig@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekkehard Gruenig, MD
Organizational Affiliation
Thoraxclinic at the University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxclinic at the University Hospital Heidelberg
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekkehard Gruenig, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17449958
Citation
Mereles D, Ewert R, Lodziewski S, Borst MM, Benz A, Olschewski H, Grunig E. Effect of inhaled iloprost during off-medication time in patients with pulmonary arterial hypertension. Respiration. 2007;74(5):498-502. doi: 10.1159/000101953. Epub 2007 Apr 20.
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Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
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