CTEPHNCT01393327
Feasibility and Influence of Exercise Therapy on Oxygen Uptake and Right Heart Function in CTEPH Patients After PEA
A study testing respiratory and exercise therapy in people with CTEPH, run by Heidelberg University at 1 site in Germany.
Trial summary
Purpose of this study is to investigate whether and to what extent a cautious respiratory and movement therapy can complement medical treatment and the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CTEPH
- What is being tested?
- respiratory and exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Dec 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent form
- men and women> 18 years <80 years
- CTEPH after pulmonary endarterectomy
Who cannot join
- Patients with signs of right heart decompensation
- acute diseases, infections, fever
- Serious lung disease with FEV1 <50% or TLC <70% of target
- Other exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, congestive heart failure, significant heart disease, pacemakers, and hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for pulmonary Hypertension, Thoraxclinic Heidelberg
Heidelberg, 69126
About this study
Official title: Feasibility and Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Heart Function in Chronic Thromboembolic Pulmonary Hypertension After Thromboendarterectomy
Purpose of this study is to investigate whether and to what extent a cautious respiratory and movement therapy can complement medical treatment and the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.
Read the detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of acute pulmonary embolism. According to current knowledge, it is caused by non-resolving fibrothrombotic obstructions of large pulmonary arteries. Some patients show an additional small vessel vasculopathy. Both kinds of obstruction lead to an increase in pulmonary vascular resistance (PVR), increase in mean pulmonary arterial pressure (mPAP), progressive right heart failure, and premature death if left untreated. Current guidelines recommend pulmonary endarterectomy (PEA) as the potentially curative treatment of first choice, which aims to remove fibrotic obstructions from the pulmonary vasculature. The survival of patients undergoing PEA surgery ranges between 76 and 91% after 3 years, which is superior to medical treatment in inoperable CTEPH patients. The majority of operated patients experience almost complete normalisation of haemodynamics and improvements in symptoms. However, 17-51% of operated patients will develop persistent or recurrent pulmonary hypertension (PH). Some patients remain limited in their exercise capacity and prognosis. As patients are monitored on an intensive care unit immediately after PEA, immobilisation after the operation may lead to further peripheral deconditioning. A recent study of 251 CTEPH patients with follow-up until 12 months after PEA showed a persistent exercise limitation in almost 40% of patients despite normalisation of PVR and haemodynamics. This limitation was characterised by a multifactorial aetiology also involving respiratory function abnormalities. Previous studies in patients with inoperable or persistent CTEPH have suggested beneficial effects of exercise training as an add-on to targeted medical therapy, increasing exercise capacity, and quality of life (QoL). However, it is not known, whether early rehabilitation with exercise treatment is safe, feasible, and may further improve exercise capacity after PEA. Prospective studies on exercise training for CTEPH patients shortly after PEA surgery are lacking. Furthermore, to the best of our knowledge, there have been no studies yet describing the early effect within the first weeks after PEA. The aim of this study was therefore to assess the feasibility of supervised exercise training in CTEPH patients shortly after PEA. Furthermore, changes of haemodynamic and clinical parameters including oxygen uptake, QoL, exercise capacity, and right heart function assessed by echocardiography and right heart catheterisation were obtained before and shortly after PEA.
- Conditions
- CTEPH
- Being tested
- respiratory and exercise therapy
- Keywords
- physical training, remaining post-operative pulmonary vascular changes, right ventricular pump function, PEA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
respiratory and exercise therapyBehavioural
Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
| Study group | Role | What they receive |
|---|---|---|
| Respiratory and exercise therapy | Experimental | Early after PEA postoperative three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. Receives: Behavioral: respiratory and exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA
Assessment of feasibility and tolerance of exercise rehabilitation directly after PEA assessed by the number of patients completing the exercise rehabilitation program
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change of peak O2 uptake (VO2peak) during exercise
Change of peak O2 uptake measured by cardiopulmonary exercise test (CPET)
Measured: up to 15 weeks after start of rehabilitation with exercise training
Secondary outcomes (28)
Change in right atrial pressure (RAP) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in right atrial pressure (RAP) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in right ventricular pressure (RVP) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in right ventricular pressure (RVP) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in systolic pulmonary arterial pressure (sPAP) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in systolic pulmonary arterial pressure (sPAP) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in diastolic pulmonary arterial pressure (dPAP) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in diastolic pulmonary arterial pressure (dPAP) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in mean pulmonary arterial pressure (mPAP) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in mean pulmonary arterial pressure (mPAP) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary arterial wedge pressure (PAWP) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary arterial wedge pressure (PAWP) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac output (CO) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac output (CO) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary vascular resistance (PVR) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary vascular resistance (PVR) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in venous oxygen saturation from pulmonary artery (SvO2) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in venous oxygen saturation from pulmonary artery (SvO2) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac index (CI) at rest
Changes in hemodynamics at rest
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac index (CI) during exercise
Changes in hemodynamics during exercise
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in exercise capacity assessed by six minute walking test
Six Minute Walking distance (6MWD) in meters
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in exercise capacity - workload
recumbent bike (Workload in Watts) during cycle Ergometer test
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in exercise capacity - respiratory economy
EqO2, EqCO2 assessed during cardiopulmonary exercise testing
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change of laboratory parameters of right heart function
Measurement of NT-proBNP
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in right atrial area
Change of cm2 of right atrial area measured by 2D echocardiography
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in right ventricular area
Change of cm2 of right ventricular area measured by 2D echocardiography
Measured: up to 15 weeks after start of rehabilitation with exercise training
Change in visual right heart pump function
Change of category of right heart pump function (no impairment, slight impairment, moderate impairment, severe impairment) measured by 2D echocardiography
Measured: up to 15 weeks after start of rehabilitation with exercise training
Safety of early rehabilitation directly after pulmonary endarterectomy: number of adverse events and serious adverse events
number of adverse events and serious adverse events
Measured: up to 15 weeks after start of rehabilitation with exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for CTEPHStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
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 Grünig, Professor, Study director, Center for pulmonary hypertension, Thoraxclinic Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393327
- Sponsor's protocol ID
- S-488/2009
- Status last verified
- May 2021
- First submitted
- 28 Jun 2011
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29.
PubMed 26826181Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
PubMed 26320113Archibald CJ, Auger WR, Fedullo PF, Channick RN, Kerr KM, Jamieson SW, Kapelanski DP, Watt CN, Moser KM. Long-term outcome after pulmonary thromboendarterectomy. Am J Respir Crit Care Med. 1999 Aug;160(2):523-8. doi: 10.1164/ajrccm.160.2.9808109.
PubMed 10430723Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Hodgkins D, Goldsmith K, Hughes RJ, Sheares K, Tsui SS, Armstrong IJ, Torpy C, Crackett R, Carlin CM, Das C, Coghlan JG, Pepke-Zaba J. Improved outcomes in medically and surgically treated chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med. 2008 May 15;177(10):1122-7. doi: 10.1164/rccm.200712-1841OC. Epub 2008 Feb 21.
PubMed 18292468Skoro-Sajer N, Marta G, Gerges C, Hlavin G, Nierlich P, Taghavi S, Sadushi-Kolici R, Klepetko W, Lang IM. Surgical specimens, haemodynamics and long-term outcomes after pulmonary endarterectomy. Thorax. 2014 Feb;69(2):116-22. doi: 10.1136/thoraxjnl-2013-203746. Epub 2013 Sep 19.
PubMed 24052543Matsuda H, Ogino H, Minatoya K, Sasaki H, Nakanishi N, Kyotani S, Kobayashi J, Yagihara T, Kitamura S. Long-term recovery of exercise ability after pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension. Ann Thorac Surg. 2006 Oct;82(4):1338-43; discussion 1343. doi: 10.1016/j.athoracsur.2006.03.105.
PubMed 16996930Wieteska M, Biederman A, Kurzyna M, Dyk W, Burakowski J, Wawrzynska L, Szturmowicz M, Fijalkowska A, Szatkowski P, Torbicki A. Outcome of Medically Versus Surgically Treated Patients With Chronic Thromboembolic Pulmonary Hypertension. Clin Appl Thromb Hemost. 2016 Jan;22(1):92-9. doi: 10.1177/1076029614536604. Epub 2014 May 28.
PubMed 24875780Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Hoeper MM, Jansa P, Kim NH, Wang C, Wilkins MR, Fritsch A, Davie N, Colorado P, Mayer E. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension: a long-term extension study (CHEST-2). Eur Respir J. 2015 May;45(5):1293-302. doi: 10.1183/09031936.00087114. Epub 2014 Nov 13.
PubMed 25395036Fukui S, Ogo T, Goto Y, Ueda J, Tsuji A, Sanda Y, Kumasaka R, Arakawa T, Nakanishi M, Fukuda T, Takaki H, Yasuda S, Ogawa H, Nakanishi N. Exercise intolerance and ventilatory inefficiency improve early after balloon pulmonary angioplasty in patients with inoperable chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2015 Feb 1;180:66-8. doi: 10.1016/j.ijcard.2014.11.187. Epub 2014 Nov 26. No abstract available.
PubMed 25438215Corsico AG, D'Armini AM, Conio V, Sciortino A, Pin M, Grazioli V, Di Vincenzo G, Di Domenica R, Celentano A, Vanini B, Grosso A, Gini E, Albicini F, Merli VN, Ronzoni V, Ghio S, Klersy C, Cerveri I. Persistent exercise limitation after successful pulmonary endoarterectomy: frequency and determinants. Respir Res. 2019 Feb 14;20(1):34. doi: 10.1186/s12931-019-1002-5.
PubMed 30764853Ehlken N, Lichtblau M, Klose H, Weidenhammer J, Fischer C, Nechwatal R, Uiker S, Halank M, Olsson K, Seeger W, Gall H, Rosenkranz S, Wilkens H, Mertens D, Seyfarth HJ, Opitz C, Ulrich S, Egenlauf B, Grunig E. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial. Eur Heart J. 2016 Jan 1;37(1):35-44. doi: 10.1093/eurheartj/ehv337. Epub 2015 Jul 31.
PubMed 26231884Grunig E, Lichtblau M, Ehlken N, Ghofrani HA, Reichenberger F, Staehler G, Halank M, Fischer C, Seyfarth HJ, Klose H, Meyer A, Sorichter S, Wilkens H, Rosenkranz S, Opitz C, Leuchte H, Karger G, Speich R, Nagel C. Safety and efficacy of exercise training in various forms of pulmonary hypertension. Eur Respir J. 2012 Jul;40(1):84-92. doi: 10.1183/09031936.00123711. Epub 2012 Feb 9.
PubMed 22323570Lankeit M, Krieg V, Hobohm L, Kolmel S, Liebetrau C, Konstantinides S, Hamm CW, Mayer E, Wiedenroth CB, Guth S. Pulmonary endarterectomy in chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2017 Jul 1:S1053-2498(17)31877-6. doi: 10.1016/j.healun.2017.06.011. Online ahead of print.
PubMed 28750932Kovacs G, Avian A, Pienn M, Naeije R, Olschewski H. Reading pulmonary vascular pressure tracings. How to handle the problems of zero leveling and respiratory swings. Am J Respir Crit Care Med. 2014 Aug 1;190(3):252-7. doi: 10.1164/rccm.201402-0269PP.
PubMed 24869464Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
PubMed 16982941
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life and Right Heart Function in Chronic Thromboembolic Pulmonary Hypertension After Thromboendarterectomy
- ClinicalTrials.gov ID
- NCT01393327
- Acronym / sponsor ID
- S-488/2009
- Conditions
- CTEPH
- Keywords
- physical training, remaining post-operative pulmonary vascular changes, right ventricular pump function, PEA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Jul 2011 (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.
Purpose of this study is to investigate whether and to what extent a cautious respiratory and movement therapy can complement medical treatment and the condition, oxygen uptake, quality of life, the pulmonary vascular pressures, the size of the right heart and the 6-minute walk distance in patients with pulmonary hypertension.
Detailed description
Chronic thromboembolic pulmonary hypertension (CTEPH) is a complication of acute pulmonary embolism. According to current knowledge, it is caused by non-resolving fibrothrombotic obstructions of large pulmonary arteries. Some patients show an additional small vessel vasculopathy. Both kinds of obstruction lead to an increase in pulmonary vascular resistance (PVR), increase in mean pulmonary arterial pressure (mPAP), progressive right heart failure, and premature death if left untreated. Current guidelines recommend pulmonary endarterectomy (PEA) as the potentially curative treatment of first choice, which aims to remove fibrotic obstructions from the pulmonary vasculature. The survival of patients undergoing PEA surgery ranges between 76 and 91% after 3 years, which is superior to medical treatment in inoperable CTEPH patients. The majority of operated patients experience almost complete normalisation of haemodynamics and improvements in symptoms. However, 17-51% of operated patients will develop persistent or recurrent pulmonary hypertension (PH). Some patients remain limited in their exercise capacity and prognosis. As patients are monitored on an intensive care unit immediately after PEA, immobilisation after the operation may lead to further peripheral deconditioning. A recent study of 251 CTEPH patients with follow-up until 12 months after PEA showed a persistent exercise limitation in almost 40% of patients despite normalisation of PVR and haemodynamics. This limitation was characterised by a multifactorial aetiology also involving respiratory function abnormalities. Previous studies in patients with inoperable or persistent CTEPH have suggested beneficial effects of exercise training as an add-on to targeted medical therapy, increasing exercise capacity, and quality of life (QoL). However, it is not known, whether early rehabilitation with exercise treatment is safe, feasible, and may further improve exercise capacity after PEA. Prospective studies on exercise training for CTEPH patients shortly after PEA surgery are lacking. Furthermore, to the best of our knowledge, there have been no studies yet describing the early effect within the first weeks after PEA. The aim of this study was therefore to assess the feasibility of supervised exercise training in CTEPH patients shortly after PEA. Furthermore, changes of haemodynamic and clinical parameters including oxygen uptake, QoL, exercise capacity, and right heart function assessed by echocardiography and right heart catheterisation were obtained before and shortly after PEA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory and exercise therapy | Experimental | Behavioral: respiratory and exercise therapyEarly after PEA postoperative three-week inpatient rehabilitation and subsequent continuing of the training at home for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consent form
- men and women> 18 years <80 years
- CTEPH after pulmonary endarterectomy
Key exclusion criteria (4 listed)
- Patients with signs of right heart decompensation
- acute diseases, infections, fever
- Serious lung disease with FEV1 <50% or TLC <70% of target
- Other exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, congestive heart failure, significant heart disease, pacemakers, and hypertrophic obstructive cardiomyopathy, or a highly reduced left ventricular function
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 |
|---|---|---|
| respiratory and exercise therapyConventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training | Behavioural | Respiratory and exercise therapy |
Primary outcome
Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Assessment of feasibility and tolerance of exercise rehabilitation directly after PEA assessed by the number of patients completing the exercise rehabilitation program
Change of peak O2 uptake (VO2peak) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change of peak O2 uptake measured by cardiopulmonary exercise test (CPET)
28 secondary outcomes
Change in right atrial pressure (RAP) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in right atrial pressure (RAP) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in right ventricular pressure (RVP) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in right ventricular pressure (RVP) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in systolic pulmonary arterial pressure (sPAP) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in systolic pulmonary arterial pressure (sPAP) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in diastolic pulmonary arterial pressure (dPAP) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in diastolic pulmonary arterial pressure (dPAP) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in mean pulmonary arterial pressure (mPAP) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in mean pulmonary arterial pressure (mPAP) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary arterial wedge pressure (PAWP) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary arterial wedge pressure (PAWP) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac output (CO) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac output (CO) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary vascular resistance (PVR) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in pulmonary vascular resistance (PVR) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in venous oxygen saturation from pulmonary artery (SvO2) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in venous oxygen saturation from pulmonary artery (SvO2) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac index (CI) at rest
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in cardiac index (CI) during exercise
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in exercise capacity assessed by six minute walking test
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in exercise capacity - workload
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in exercise capacity - respiratory economy
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change of laboratory parameters of right heart function
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in right atrial area
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in right ventricular area
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Change in visual right heart pump function
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Safety of early rehabilitation directly after pulmonary endarterectomy: number of adverse events and serious adverse events
Time frame: up to 15 weeks after start of rehabilitation with exercise training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Results publication: PubMed 26826181Delcroix M, Lang I, Pepke-Zaba J, Jansa P, D'Armini AM, Snijder R, Bresser P, Torbicki A, Mellemkjaer S, Lewczuk J, Simkova I, Barbera JA, de Perrot M, Hoeper MM, Gaine S, Speich R, Gomez-Sanchez MA, Kovacs G, Jais X, Ambroz D, Treacy C, Morsolini M, Jenkins D, Lindner J, Dartevelle P, Mayer E, Simonneau G. Long-Term Outcome of Patients With Chronic Thromboembolic Pulmonary Hypertension: Results From an International Prospective Registry. Circulation. 2016 Mar 1;133(9):859-71. doi: 10.1161/CIRCULATIONAHA.115.016522. Epub 2016 Jan 29.
- Results publication: PubMed 26320113Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
- Results publication: PubMed 10430723Archibald CJ, Auger WR, Fedullo PF, Channick RN, Kerr KM, Jamieson SW, Kapelanski DP, Watt CN, Moser KM. Long-term outcome after pulmonary thromboendarterectomy. Am J Respir Crit Care Med. 1999 Aug;160(2):523-8. doi: 10.1164/ajrccm.160.2.9808109.
- Results publication: PubMed 18292468Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Hodgkins D, Goldsmith K, Hughes RJ, Sheares K, Tsui SS, Armstrong IJ, Torpy C, Crackett R, Carlin CM, Das C, Coghlan JG, Pepke-Zaba J. Improved outcomes in medically and surgically treated chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med. 2008 May 15;177(10):1122-7. doi: 10.1164/rccm.200712-1841OC. Epub 2008 Feb 21.
- Results publication: PubMed 24052543Skoro-Sajer N, Marta G, Gerges C, Hlavin G, Nierlich P, Taghavi S, Sadushi-Kolici R, Klepetko W, Lang IM. Surgical specimens, haemodynamics and long-term outcomes after pulmonary endarterectomy. Thorax. 2014 Feb;69(2):116-22. doi: 10.1136/thoraxjnl-2013-203746. Epub 2013 Sep 19.
- Results publication: PubMed 16996930Matsuda H, Ogino H, Minatoya K, Sasaki H, Nakanishi N, Kyotani S, Kobayashi J, Yagihara T, Kitamura S. Long-term recovery of exercise ability after pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension. Ann Thorac Surg. 2006 Oct;82(4):1338-43; discussion 1343. doi: 10.1016/j.athoracsur.2006.03.105.
- Results publication: PubMed 24875780Wieteska M, Biederman A, Kurzyna M, Dyk W, Burakowski J, Wawrzynska L, Szturmowicz M, Fijalkowska A, Szatkowski P, Torbicki A. Outcome of Medically Versus Surgically Treated Patients With Chronic Thromboembolic Pulmonary Hypertension. Clin Appl Thromb Hemost. 2016 Jan;22(1):92-9. doi: 10.1177/1076029614536604. Epub 2014 May 28.
- Results publication: PubMed 25395036Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Hoeper MM, Jansa P, Kim NH, Wang C, Wilkins MR, Fritsch A, Davie N, Colorado P, Mayer E. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension: a long-term extension study (CHEST-2). Eur Respir J. 2015 May;45(5):1293-302. doi: 10.1183/09031936.00087114. Epub 2014 Nov 13.
- Results publication: PubMed 25438215Fukui S, Ogo T, Goto Y, Ueda J, Tsuji A, Sanda Y, Kumasaka R, Arakawa T, Nakanishi M, Fukuda T, Takaki H, Yasuda S, Ogawa H, Nakanishi N. Exercise intolerance and ventilatory inefficiency improve early after balloon pulmonary angioplasty in patients with inoperable chronic thromboembolic pulmonary hypertension. Int J Cardiol. 2015 Feb 1;180:66-8. doi: 10.1016/j.ijcard.2014.11.187. Epub 2014 Nov 26. No abstract available.
- Results publication: PubMed 30764853Corsico AG, D'Armini AM, Conio V, Sciortino A, Pin M, Grazioli V, Di Vincenzo G, Di Domenica R, Celentano A, Vanini B, Grosso A, Gini E, Albicini F, Merli VN, Ronzoni V, Ghio S, Klersy C, Cerveri I. Persistent exercise limitation after successful pulmonary endoarterectomy: frequency and determinants. Respir Res. 2019 Feb 14;20(1):34. doi: 10.1186/s12931-019-1002-5.
- Results publication: PubMed 26231884Ehlken N, Lichtblau M, Klose H, Weidenhammer J, Fischer C, Nechwatal R, Uiker S, Halank M, Olsson K, Seeger W, Gall H, Rosenkranz S, Wilkens H, Mertens D, Seyfarth HJ, Opitz C, Ulrich S, Egenlauf B, Grunig E. Exercise training improves peak oxygen consumption and haemodynamics in patients with severe pulmonary arterial hypertension and inoperable chronic thrombo-embolic pulmonary hypertension: a prospective, randomized, controlled trial. Eur Heart J. 2016 Jan 1;37(1):35-44. doi: 10.1093/eurheartj/ehv337. Epub 2015 Jul 31.
- Results publication: PubMed 22323570Grunig E, Lichtblau M, Ehlken N, Ghofrani HA, Reichenberger F, Staehler G, Halank M, Fischer C, Seyfarth HJ, Klose H, Meyer A, Sorichter S, Wilkens H, Rosenkranz S, Opitz C, Leuchte H, Karger G, Speich R, Nagel C. Safety and efficacy of exercise training in various forms of pulmonary hypertension. Eur Respir J. 2012 Jul;40(1):84-92. doi: 10.1183/09031936.00123711. Epub 2012 Feb 9.
Related trials for CTEPH
Not yet recruiting
Home-based Inspiratory Muscle Training in Pulmonary Hypertension
Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension
RecruitingObservational study
Early Detection of CTEPH in Patients After APE
Chronic Pulmonary Thromboembolism
Recruiting
The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy
LEVOSIMENDAN, PULMONARY THROMBOENDARTERECTOMY
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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 Grünig, Professor study director
Center for pulmonary hypertension, Thoraxclinic 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 respiratory and exercise therapy in people with CTEPH, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 10 May 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate of exercise rehabilitation program training by CTEPH patients directly after PEA (time frame: up to 15 weeks after start of rehabilitation with exercise training). 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 NCT01393327, which also lists 29 linked publications.
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 10 May 2021.