Prospective Registry to Evaluate the Effective Incidence of Chronic Thromboembolic Pulmonary Hypertension in Germany
Study Details
Study Description
Brief Summary
The incidence of chronic thromboembolic pulmonary hypertension (CTEPH) after acute pulmonary embolism ist not clear. It is estimated to be up to 3.8%. Prospective data registration does not exist. Treatment of choice is pulmonary endarterectomy if the thromboembolic lesions are surgically accessible. Otherwise interventional therapy by means of pulmonary balloon-angioplasty (BPA) or medical therapy is indicated. In Germany, the majority of the patients is referred to three CTEPH centers: Kerckhoff Clinic, Saarland University Hospital and Hannover Medical School to evaluate the therapeutic options. Starting in January 2016 all incident patients will be de-identified and included prospectively. Risk factors, outcome and treatment will be documented.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
All patients referred to the participating centers will be diagnosed in a standardized manner to confirm the diagnosis "CTEPH". No additional intervention or blood sampling is necessary. The recommended treatment option is the result of weekly CTEPH conferences. Every patient will be discussed.
The registry contains the following data:
Center PLZ Sex Age Body Mass Index History of venous thromboembolism (VTE), Date ff 1st VTE Anticoagulation and type of anticoagulation Blood group V/Q scan CT-agiography Pulmonary angiogram World Health Organisation-Functional Class six-minute walk distance Right heart catheter: RAP, PAPs, PAPd, PAPm, PAWP, CO, CI, PVR, SvO2 Treatment: PEA, Ballon Pulmonary
Angioplasty (BPA), medically therapy, Vena cava filter CTEPH special risk factors:
thrombophilia, antiphospholipid antibody syndrome, splenectomy, VA shunt; pacemakers
Study Design
Outcome Measures
Primary Outcome Measures
- Diagnosis "CTEPH" confirmed [12 months]
Aim of the study is to detect prospectively the incidence of the diagnosis CTEPH during one year in Germany.
- Treatment [12 months]
Registration of the frequency of different treatment options, e.g. pulmonary endarterectomy, pulmonary ballon-angioplasty and medical therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
- diagnosis "CTEPH" confirmed
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kerckhoff Clicic | Bad Nauheim | Germany | 61231 | |
| 2 | Hannover Medical School | Hannover | Germany | 30625 |
Sponsors and Collaborators
- Kerckhoff Klinik
- Hannover Medical School
- University Hospital, Saarland
Investigators
- Study Chair: Eckhard Mayer, Prof. Dr., Kerckhoff Klinik, Bad Nauheim, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
- Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Goldsmith K, Coghlan JG, Pepke-Zaba J. Prognostic and aetiological factors in chronic thromboembolic pulmonary hypertension. Eur Respir J. 2009 Feb;33(2):332-8. doi: 10.1183/09031936.00092008. Epub 2008 Oct 1.
- Condliffe 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.
- McGoon MD, Benza RL, Escribano-Subias P, Jiang X, Miller DP, Peacock AJ, Pepke-Zaba J, Pulido T, Rich S, Rosenkranz S, Suissa S, Humbert M. Pulmonary arterial hypertension: epidemiology and registries. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D51-9. doi: 10.1016/j.jacc.2013.10.023. Review.
- CTEPH-2016