NCT02660463

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

January 12, 2016

Last Update Submit

January 20, 2016

Conditions

CTEPHChronic Thromboembolic Pulmonary Hypertension

Keywords

incidencerisk factors

Outcome Measures

Primary Outcomes (2)

  • Diagnosis "CTEPH" confirmed

    Aim of the study is to detect prospectively the incidence of the diagnosis CTEPH during one year in Germany.

    12 months

  • Treatment

    Registration of the frequency of different treatment options, e.g. pulmonary endarterectomy, pulmonary ballon-angioplasty and medical therapy

    12 months

Interventions

Registration of the diagnosis "CTEPH"OTHER

Registration of risk factors for thromboembolic events

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Any patient with confirmed CTEPH during the year 2016 or not diagnosis confirmation not more than 6 months ago

You may qualify if:

  • diagnosis "CTEPH" confirmed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kerckhoff Clicic

Bad Nauheim, 61231, Germany

RECRUITING

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

Related Publications (5)

  • 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.

    PMID: 18829679BACKGROUND

  • 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.

    PMID: 18292468BACKGROUND

  • 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.

    PMID: 24355642BACKGROUND

  • 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.

    PMID: 22221974RESULT

  • 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.

    PMID: 29450722DERIVED

Study Officials

  • Eckhard Mayer, Prof. Dr.

    Kerckhoff Klinik, Bad Nauheim, Germany

    STUDY CHAIR

Central Study Contacts

Thorsten Kramm, Dr.

CONTACT

+49 6032 996 2402t.kramm@kerckhoff-klinik.de

Stefan Guth, Dr.

CONTACT

+49 6032 996 2402s.guth@kerckhoff-klinik.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Thorsten Kramm, M.D.

Study Record Dates

First Submitted

January 12, 2016

First Posted

January 21, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations

DE(2)