Pulmonary HypertensionNCT00477724
Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
A study testing exercise and respiratory therapy in people with Pulmonary Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by Heidelberg University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Hypertension, Chronic Thromboembolic Pulmonary Hypertension
- What is being tested?
- exercise and respiratory therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxclinic at the University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Ekkehard Gruenig, MD
About this study
Official title: Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy
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.
Read more
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.
- Being tested
- exercise and respiratory therapy, sedentary control group
- Keywords
- latent
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and respiratory therapyBehavioural
exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
sedentary control groupOther
control group with no specific training
| Study group | Role | What they receive |
|---|---|---|
| sedentary control group | Placebo comparator | patients are treated by conventional rehabilitation Receives: Other: sedentary control group |
| exercise and respiratory therapy | Active comparator | rehabilitation with exercise and respiratory therapy Receives: Behavioral: exercise and respiratory therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 6-Minute walking test
Measured: after 3 and 15 weeks compared to baseline
Change in quality of life
Measured: baseline and 15 weeks
Secondary outcomes (8)
physical capacity in the ergometer test
Measured: baseline, 3 and 15 weeks
change of lung function during 6-minute walking test
Measured: baseline, 3 and 15 weeks
noninvasive hemodynamic parameters
Measured: baseline, 3 and 15 weeks
change of systolic pulmonary arterial pressure at rest and during exercise
Measured: baseline, 3 and 15 weeks
change of WHO functional class
Measured: baseline, 3 and 15 weeks
change of perfusion parameters (MRI)
Measured: baseline, 3 and 15 weeks
change of respiratory muscle function
Measured: baseline and 15 weeks
change of NTproBNP
Measured: baseline, 3 and 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
- Investigators
- Ekkehard Gruenig, MD, Principal investigator, Thoraxclinic at the University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477724
- Sponsor's protocol ID
- REHA/CTEPH
- Status last verified
- Jul 2022
- First submitted
- 22 May 2007
- Last updated
- 14 Jul 2022
- Results posted
- No
Publications
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.
PubMed 17449958
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy
- ClinicalTrials.gov ID
- NCT00477724
- Acronym / sponsor ID
- REHA/CTEPH
- Keywords
- latent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sedentary control group | Placebo comparator | Other: sedentary control grouppatients are treated by conventional rehabilitation |
| exercise and respiratory therapy | Active comparator | Behavioral: exercise and respiratory therapyrehabilitation with exercise and respiratory therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A Screening
- B Training
- Latent pulmonary hypertension
- Restricted physical capacity
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise and respiratory therapyexercise and respiratory therapy for three weeks in-hospital and 15 weeks at home | Behavioural | exercise and respiratory therapy |
| sedentary control groupcontrol group with no specific training | Other | sedentary control group |
Primary outcome
Change in 6-Minute walking test
Time frame: after 3 and 15 weeks compared to baseline
Change in quality of life
Time frame: baseline and 15 weeks
8 secondary outcomes
physical capacity in the ergometer test
Time frame: baseline, 3 and 15 weeks
change of lung function during 6-minute walking test
Time frame: baseline, 3 and 15 weeks
noninvasive hemodynamic parameters
Time frame: baseline, 3 and 15 weeks
change of systolic pulmonary arterial pressure at rest and during exercise
Time frame: baseline, 3 and 15 weeks
change of WHO functional class
Time frame: baseline, 3 and 15 weeks
change of perfusion parameters (MRI)
Time frame: baseline, 3 and 15 weeks
change of respiratory muscle function
Time frame: baseline and 15 weeks
change of NTproBNP
Time frame: baseline, 3 and 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 17449958Mereles 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekkehard Gruenig, MD principal investigator
Thoraxclinic at the University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise and respiratory therapy in people with Pulmonary Hypertension and Chronic Thromboembolic Pulmonary Hypertension, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekkehard Gruenig, MD (+49 6221 396 80 53, ekkehard.gruenig@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 6-Minute walking test (time frame: after 3 and 15 weeks compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00477724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.