Prospective Registry to Evaluate the Effective Incidence of Chronic Thromboembolic Pulmonary Hypertension in Germany

NCT ID: NCT02660463

Last Updated: 2016-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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CTEPH Chronic Thromboembolic Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Registration of the diagnosis "CTEPH"

Registration of risk factors for thromboembolic events

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* diagnosis "CTEPH" confirmed

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role collaborator

University Hospital, Saarland

OTHER

Sponsor Role collaborator

Kerckhoff Klinik

OTHER

Sponsor Role lead

Responsible Party

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Dr. Thorsten Kramm

Dr. Thorsten Kramm, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eckhard Mayer, Prof. Dr.

Role: STUDY_CHAIR

Kerckhoff Klinik, Bad Nauheim, Germany

Locations

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Kerckhoff Clicic

Bad Nauheim, , Germany

Site Status RECRUITING

Hannover Medical School

Hanover, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Thorsten Kramm, Dr.

Role: CONTACT

+49 6032 996 2402

Stefan Guth, Dr.

Role: CONTACT

+49 6032 996 2402

Facility Contacts

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Thorsten Kramm, Dr.

Role: primary

+49 6032 996 2402

Stefan Guth, Dr.

Role: backup

+49 6032 996 2402

Marius Hoeper, MD PhD

Role: primary

+49 511 5323530

Karen Olsson, MD

Role: backup

+49 511 5323530

References

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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.

Reference Type BACKGROUND
PMID: 18829679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18292468 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24355642 (View on PubMed)

Wilkens H, Lang I, Behr J, Berghaus T, Grohe C, Guth S, Hoeper MM, Kramm T, Kruger U, Langer F, Rosenkranz S, Schafers HJ, Schmidt M, Seyfarth HJ, Wahlers T, Worth H, Mayer E. Chronic thromboembolic pulmonary hypertension (CTEPH): updated Recommendations of the Cologne Consensus Conference 2011. Int J Cardiol. 2011 Dec;154 Suppl 1:S54-60. doi: 10.1016/S0167-5273(11)70493-4.

Reference Type RESULT
PMID: 22221974 (View on PubMed)

Kramm T, Wilkens H, Fuge J, Schafers HJ, Guth S, Wiedenroth CB, Weingard B, Huscher D, Pittrow D, Cebotari S, Hoeper MM, Mayer E, Olsson KM. Incidence and characteristics of chronic thromboembolic pulmonary hypertension in Germany. Clin Res Cardiol. 2018 Jul;107(7):548-553. doi: 10.1007/s00392-018-1215-5. Epub 2018 Feb 15.

Reference Type DERIVED
PMID: 29450722 (View on PubMed)

Other Identifiers

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CTEPH-2016

Identifier Type: -

Identifier Source: org_study_id

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